CDSCO risk classification
Operation Theatre medical device classification
Every operation theatre device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 136 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 224
- Class A
- 158
- Class B
- 35
- Class C
- 26
- Class D
- 5
Operation Theatre devices and their class
224 devices
Abdominal scissors, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to cut the abdominal tissue, in particular the abdominal wall tissue, during surgery. This is a transient- use, reusable device intended to be sterilized prior to use.
Adaptor, light source
Operation Theatre
Class ANon-sterile, non-measuringIntended to permit the connection of the devices that together deliver light to a work field from a light source.
Alignment guide for orthopedic fixation
Operation Theatre
Class ANon-sterile, non-measuringA reusable instrument intended to facilitate the correct orientation (alignment) of an implant during a surgical procedure. This is a non- measuring device intended for transient use.
Anatomical model for surgical planning
Operation Theatre
Class ANon-sterile, non-measuringA 3-D printed patient specific model of an organ (e.g., heart, kidney, lung) or bone(s) intended to be used to assist peri-operative anatomical visualisation and surgical treatment planning. It is created using 3-D Printing processes based on patient medical images.
Aneurysm clip applier, reusable
Operation Theatre
Class ANon-sterile, non-measuringA surgical instrument intended for the application/insertion of aneurysm clips (not included). This is a reusable device.
Arm board pad
Operation Theatre
Class ANon-sterile, non-measuringIt is intended to provide support to the patients arm during prolonged surgeries.
Aspiration Canister, single-use
Operation Theatre
Class AA non-invasive, sterile container intended for use as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, thrombi, etc.) from a surgical site for disposal and/or to prevent backflow. It may contain accessories such as hydrophobic filter, lid, etc. This is a single-use device.
Autopsy Kit
Operation Theatre
Class AThe Autopsy Kit is a collection of reusable, non-sterile, manually operated surgical instruments intended for use by trained professionals during post-mortem examination procedures. The instruments are designed to perform basic mechanical functions such as grasping, cutting, dissecting, probing, retracting, and measuring anatomical structures of deceased human bodies. It may have measuring devices (callipers, measuring tapes, etc.).
Blepharoplasty scissors, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). This is a reusable device.
Bone distraction forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual, open-surgery instrument intended to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. This is a reusable device.
Box Wrench for Nut/Bolt, reusable
Operation Theatre
Class ANon-sterile, non-measuringA minimally invasive, hand-held manual surgical instrument intended to grip, twist or turn nut and bolt during orthopedic surgery. This is a reusable device.
Bulldog clamp forceps/ Clamp manipulation forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. This is a reusable device intended to be sterilized prior to use (transient duration).
Camera Arm Sterile Adapter
Operation Theatre
Class AA sterile device intended to provide a sterile interface for securely attaching the camera arm to the sterile drape, allowing safe passage and positioning of the endoscope during surgical procedures. It may be single-use or reusable device.
Camera for medical applications
Operation Theatre
Class ANon-sterile, non-measuringA non-invasive camera intended to be used with microscopes, colposcopes and on endoscopic procedures for recording and capturing of images of internal structures. This does not have any AI- integrated or image analysis functions.
Cartilage knife/ Chondrotome, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for cutting, shaving or shaping cartilage during a surgical intervention. This is a reusable device.
Circumcision kit, reusable
Operation Theatre
Class ANon-sterile, non-measuringA collection of various non-sterile, non-powered, reusable instruments, dressings, etc. intended to perform a circumcision procedure. Typical components include circumcision clamp, scissors, and scalpel. This is a non-measuring, reusable device and does not contain pharmaceuticals.
Clamp, reusable
Operation Theatre
Class ANon-sterile, non-measuringA handheld surgical instrument intended for clamping tissues or materials or bone other than in central circulatory/central nervous system. This is a reusable device intended for transient use.
Clamping and Occluding Surgical instruments
Operation Theatre
Class AThese are transient use invasive surgical instruments, intended for use in many surgical procedures for compressing blood vessels or hollow organs. In order to prevent their contents from leaking or control bleeding or Occlude. They are designed straight, curved or angled, or ratcheted and have a variety of inner jaw patterns.
Closed Wound Drainage Tube or System
Operation Theatre
Class BA surgical drain is a tube used to remove pus, blood or other fluids from a wound. They are commonly placed by surgeons or interventional radiologists.
Continuous Irrigation Catheter
Operation Theatre
Class BIntended to be used to introduce fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
Cruciate Ligament Reconstruction Instruments with Ligament Graft Fixation Devices
Operation Theatre
Class CIt is a set of reusable devices intended for ACL & PCL Reconstruction. Instruments are manual, hand-held surgical instruments used during orthopaedic surgery and include associated non-bioabsorbable fixation devices.
Cutting and Dissecting Surgical instruments
Operation Theatre
Class AThese are transient use invasive surgical instruments, usually have sharp edges or tips to cut through skin, tissue, and suture material. Intended to cut and dissect tissue to explore irregular growths and to remove dangerous or damaged tissue. Also used for cutting sutures.
Cystoscopic rongeur, reusable
Operation Theatre
Class ANon-sterile, non-measuringA rigid, hand-held manual instrument intended to be used with a compatible rigid cystoscope for the removal of hard/tough tissue (e.g., calculi) from the urinary tract during a cystoscopic procedure. It is introduced into the body through an artificial orifice or the working channel of the endoscope. This is a reusable device.
Depezzer Catheter
Operation Theatre
Class BA tubular, flexible instrument, passed through body channels for withdrawal of fluids from a body cavity.
Disposable Suture Holder
Operation Theatre
Class AA sterile, non-powered device intended to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure.
Dissection board
Operation Theatre
Class ANon-sterile, non-measuringA reusable device on which an object is placed for support during dissection procedures.
Distractor/Retractors
Operation Theatre
Class AA surgical device used to separate connected surfaces, and to retain their positions to allow a surgical operation to be performed.
Dressing/utility forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual instrument intended primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure it is neither intended for tissue manipulation nor endoscopic use. This is a reusable device intended to be sterilized prior to use.
Driver/extractor, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manually-operated, combination surgical instrument intended to be used in the insertion and/or removal of, e.g a pin, screw or appliance during surgical procedures. This is a reusable, non-measuring device intended for transient use.
Electrosurgical electrode holder
Operation Theatre
Class ANon-sterile, non-measuringA device intended to be used to house active hand-controlled electrosurgical electrodes (pencil electrodes) when not in use during the surgical procedure. The electrosurgery electrodes are not included.
Electrosurgical Electrode Insulating Shield
Operation Theatre
Class BA non-powered accessory intended for covering the shaft of an endoscopic electrosurgical electrode to provide insulation and manage high-frequency leakage of current from the electrode during endotherapy (e.g., laparoscopic procedures, etc.). This is a single-use device.
Electrosurgical Handpiece with Electrode, single-use
Operation Theatre
Class CA sterile device, consisting of an electrosurgical handpiece and bipolar/monopolar electrode, intended to deliver electrosurgical current from an electrosurgical generator unit [not included] directly to tissues for cutting/coagulation during a surgical procedure. This is not intended for use in direct contact with the central nervous system or the heart/coronary vessels. This is a single-use device.
Endoscope Calibration Cover
Operation Theatre
Class ANon-sterile, non-measuringA non-powered endoscope accessory intended to be placed onto the distal end of an endoscope to allow white balance and/or 3-D adjustment to be calibrated in the electronic control unit of the endoscope. It may also provide a visual reference for correct positioning of the endoscope tip during 3D calibration. This is a reusable device.
Endoscope camera adaptor/coupler, reusable
Operation Theatre
Class ANon-sterile, non-measuringAn optical device intended to connect/couple a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers.This is a reusable device.
Endoscope camera, noninvasive
Operation Theatre
Class ANon-sterile, non-measuringA non-invasive device intended to provide illumination, visualization and capture of still and motion pictures of surgical sites during diagnostic and operative arthroscopic and endoscopic procedures, without having a measuring function.This may include accessories such as camera holder, cable, charger, batteries. This does not include endoscope.
Endoscope Obturator, reusable
Operation Theatre
Class ANon-sterile, non-measuringA non-powered, manual device intended for use with a compatible endoscope/cannula to establish a port of entry for endoscopes and other instruments during endoscopic surgeries. This is a transient-use, reusable device intended to be sterilized prior to use.
Endoscopic Cannula Seal Reducer, single-use
Operation Theatre
Class BA non-powered accessory to an endosopic surgical system intended to reduce the sealing diameter of an existing endoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent endoscopic sleeve whilst maintaining a seal and inhibiting leakage throughout the procedure. This is a single-use device.
Endoscopic Fluorescence Camera/Light Source Unit
Operation Theatre
Class ANon-sterile, non-measuringA powered, non-invasive unit, consisting of an endoscope camera, light source and image processing unit, intended for use in conjunction with an endoscope [not included] to: i) provide a source of cold light for endoscopic imaging, and ii) real-time visualization and recording of the internal anatomy during an endoscopic surgical procedure. This contains an integrated fluorescence imaging unit for capturing and processing of fluorescent images of anatomical structures upon dye absorption. This is not a diagnostic aid or a standalone intraoperative fluorescence tumor marking system. This does not control an endoscope.
Endoscopic Scissors, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, surgical instrument intended to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is not an electrosurgical device. This is a reusable device intended to be sterilized prior to use.
Endoscopic/Thoracoscopic Insufflator
Operation Theatre
Class CA powered device intended for use with compatible tube sets during diagnostic and/or therapeutic endoscopic and thoracoscopic procedures to distend a cavity by filling it with gas. Intended cavities for this device include abdominal and thoracic cavities. This is a reusable device.
Fibreoptic general-purpose ophthalmic hook, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument inserted into the eye during surgical intervention to manipulate anatomical structures or foreign bodies within the eye and simultaneously conduct a field of cold light to illuminate the surgical site. This is a reusable device intended for transient use.
Fistula hook, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand held, manual surgical instrument intended for hooking into or around a fistula during a surgical intervention. It is a reusable device intended for transient use.
Fistula probe, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula and not intended for probing heart valves. This is a reusable device.
Fluid Delivery tubing
Operation Theatre
Class BTube used to deliver fluid in body.
Forceps, biopsy/Open- surgery biopsy forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination it is not intended for endoscopic or catheterized access.
Forceps, dissecting, tweezers/scissors-like, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to facilitate grasping, manipulation, compression or joining of tissue during dissection and/or autopsy. This is a transient-use, reusable device intended to be sterilized prior to use.
Forceps, dressing
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual instrument intended primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure it is neither intended for tissue manipulation nor endoscopic use. This is a reusable device intended to be sterilized prior to use.
Forceps, endoscopic
Operation Theatre
Class BGrasping Forceps device is intended to be used to grasp tissue, retrieve foreign endoscopic bodies, and remove tissue from within the gastrointestinal tract.
General-purpose curette, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for scraping and/or excising tissue from a wide variety of anatomical sites, and may include non- dermal application (i.e., non-dedicated). Not intended for direct contact with the central circulatory or the central nervous system. This is a reusable device intended to be sterilized prior to use.
General-purpose diagnosis/treatment table
Operation Theatre
Class ANon-sterile, non-measuringA table for general diagnosis and procedures in examination room to aid in patient examination.
General-purpose electrosurgical unit
Operation Theatre
Class CA unit used to resect/ablate the tissue or to coagulate the incision/wound site with high-frequency waves.
General-purpose manually-operated operation table
Operation Theatre
Class ANon-sterile, non-measuringA completely mobile surgical table (general-purpose) that has been improved to make it usable for almost all parts of the body that require surgery. Manual or hydraulic operation.
General-purpose surgical spatula, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to manipulate tissue during various types of surgical interventions. This is a reusable device intended for transient use.
Grasping and Holding Surgical instruments
Operation Theatre
Class AThese transient use invasive surgical instruments are intended to grasp and hold tissue or blood vessels that may be in the way during a surgical procedure. Designed serrated or non-serrated at the tip.
Haemostatic Dressing Gauze, non-absorbable, biopolymer-based
Operation Theatre
Class CA non-absorbable dressing, containing hydrophilic biopolymer (such as chitosan or alginate), intended to control or stop mild, moderate and severe bleeding for the management of surgical sites, abrasions, lacerations, contusions, puncture wounds, traumatic injuries, and dental applications such as post-extraction bleeding, etc. It acts by producing a water-absorbent gel upon contact with wound exudate; it does not contain antimicrobial agent. It is not a standalone haemostatic gel/powder. This is a single-use device.
Hand-held surgical retractor, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery. This is a reusable device intended to be sterilized prior to use. It is intended for transient use.
Handgrip cover for surgical light
Operation Theatre
Class ANon-sterile, non-measuringIntended to provide physical barrier on a handgrip to prevent cross-contamination between the operating room surgical lights (non-sterile) and the operating room personnel.
Head Rest/Ring
Operation Theatre
Class ANon-sterile, non-measuringIntended to position and protect a patients head, face and neck during prolonged surgeries.
Hemostatic knife
Operation Theatre
Class BThe blade intended to transmits heat directly to body tissues to achieve hemostasis.
Hernia mesh
Operation Theatre
Class CIndicated to reinforce soft tissue where weakness exists, i.e., repair of hernias and chest wall defects.
High-flow blood transfusion pump
Operation Theatre
Class CA device to be used for rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries.
Hip pad positioning device
Operation Theatre
Class ANon-sterile, non-measuringIt is used to support the patient hip during prolonged surgeries.
Hook, surgical, general- purpose
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention it is not a blade-style retractor. This is a reusable device. Not intended for direct contact with central circulatory/central nervous system.
Hook, surgical, tendon/Soft- tissue surgical hook, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). This is a reusable device. Not intended for direct contact with central circulatory/central nervous system.
Intraluminal Circular Stapler Reload
Operation Theatre
Class CA sterile, non-absorbable, implantable device intended to be used in conjunction with a compatible circular stapler instrument for resection, transection, and/or creation of anastomoses during surgical interventions.
Intraoperative chest positioner
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile, preformed reusable pad intended to be attached to an operating table for stabilizing a patients chest (shoulders, pelvis, etc.) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures. This is a reusable device.
Intravenous access monitoring system, line- disconnection
Operation Theatre
Class ANon-sterile, non-measuringAn alarm system intended to connect to sensors (not included) around/on a venous puncture site dressing or catheter connection to detect blood or disconnection of the catheter.
Intravenous catheter holder, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringIt is a skin adhesive device for the securement of urinary catheters and medical tubing as part of ongoing catheter care.
Knife handle/ Scalpel handle, reusable
Operation Theatre
Class ANon-sterile, non-measuringA device intended to mount a compatible scalpel blade. This is a reusable device.
Knife sharpener
Operation Theatre
Class ANon-sterile, non-measuringA device intended to create or re-establish a thin, keen edge or fine point on an instrument used to cut during surgical procedures, such as a knife.
Laparoscopic cannula seal, single-use
Operation Theatre
Class BA sterile, non-powered, non-invasive device intended to be fitted into the proximal end of a laparoscopic access cannula to create a seal between the cannula and an introduced laparoscopic instrument, for inhibition of insufflation gas leakage. This is a single-use device.
Laparoscopic Insufflator
Operation Theatre
Class BA powered device intended to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing with a space (pneumoperitoneum) for an examination or surgical intervention. This is not intended for thoracoscopic use.
Laparoscopic tray
Operation Theatre
Class ANon-sterile, non-measuringIntended for holding laparoscopy instruments during a laparoscopic intervention or sterilization.
Leg intraoperative repositioning support
Operation Theatre
Class ANon-sterile, non-measuringA mechanical device intended to be used to help support the weight of a patients leg when the leg needs to be repositioned during an orthopaedic procedure. It is designed to be attached to the operating table.
Ligament reconstruction instrument set, reusable
Operation Theatre
Class ANon-sterile, non-measuringA collection of hand-held, manual, non- measuring surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It may consist of drill bits, reamers, burs, pushers, introducers, impactor, surgical hammer, etc. This is a reusable device intended to be sterilized prior to use.
Long-term use enterostomy feeding tube
Operation Theatre
Class CA hollow device to be placed surgically in the stomach, duodenum or jejunum to provide enteral nutrition. It is for long-term use.
Lower-limb warming sock/stocking
Operation Theatre
Class ANon-sterile, non-measuringIntended to be worn on the feet and/or legs of a patient to minimize loss of body heat during surgeries, treatment, birthing, or general hospitalization.
Manual dental torque wrench, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held device intended to be used to manually tighten dental implants and/or retaining screws fitted into the oral cavity during a dental surgical procedure. This is a reusable, non- measuring device.
Manual scalpel blade, reusable
Operation Theatre
Class ANon-sterile, non-measuringA surgical instrument intended to mount a compatible handle and function as the cutting edge of a scalpel for manually cutting and dissecting tissues. This is a reusable device.
Mechanical Peripheral Thrombectomy System
Operation Theatre
Class BA mechanical device consisting of a delivery catheter, a thrombectomy wire-net/basket, and a funnel catheter for non-surgical, mechanical capture and removal of thrombi (or, emboli) from the peripheral arterial vasculature. It is not intended for use in the central circulatory system or intracranial vasculature. This is not intended for long-term use. This may consist accessories for loading/retrieval of wire-net (e.g., guide sheath, loading device, etc.).
Medical Equipment/Instrument Drape, single-use, sterile
Operation Theatre
Class AA sterile, noninvasive protective barrier intended to cover and protect the equipment/instrument from soiling and/or contamination. This is not a dedicated cap or cover, or a transducer cover. This is a single-use device.
Microscope cover
Operation Theatre
Class ANon-sterile, non-measuringThis is a device which is usually shaped to fit the surgical camera/microscope that is intended to be used as a physical barrier to prevent cross- contamination between staff or patients during examination.
Motorized diagnostic imaging view box
Operation Theatre
Class ANon-sterile, non-measuringA device equipped with an electric mechanical or software controlled motor that retains, retrieves, and projects light for direct observation of medical images taken using a variety of methods such as X‐ray, magnetic resonance (MR), CT, and ultrasound, and recorded in radiographic film.
Multiparameter monitor with critical parameters
Operation Theatre
Class CA unit that collects monitoring parameters (include an electrocardiogram (ECG), blood pressure, body temperature, cardiac output, and respiratory gases in addition, other critical parameters (supporting detection of arrhythmia or apnea and in the case of anesthesia, determination of dose levels of a relaxant or local anaesthesia) using an embedded function kit, module, or other devices to display data, by bed or by patient.
Nail splitting scissors, reusable
Operation Theatre
Class ANon-sterile, non-measuringA surgical instrument intended for the purpose of cutting and splitting a finger or toenail, typically for removal, during a surgical intervention. This is a reusable device.
Needle Electrode
Operation Theatre
Class CThe needle electrode family is intended to be used in conjunction with the RF generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
Negative pressure wound therapy bandage
Operation Theatre
Class CIntended to generate negative pressure or suction to remove wound exudates , infection materials and tissue debris from the wound bed which may promote wound healing.
Negative-pressure wound therapy (NPWT) dressing set
Operation Theatre
Class CA collection of sterile devices, consisting of NPWT foam dressing(s), adhesive drape(s), tubing, tubing connectors, and other non-powered accessories, etc, intended for use in conjunction with an NPWT suction system [not included], to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers, etc. It is a single-use device.
Nerve/vessel retractor/hook, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. This is a reusable device intended for transient use.
Non-sterile Blood vessel surgical stripper
Operation Theatre
Class AA surgical instrument used for complete or partial vascular resection.
Non-sterile Hemostatic clip applier
Operation Theatre
Class ANon-sterile, non-measuringA surgical device designed to apply a hemostatic clip for ligation of a blood vessel.
Non-sterile Scalpel
Operation Theatre
Class AAn instrument used to sever and separate body tissues during surgery.
Non-sterile Staple remover
Operation Theatre
Class AA metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stay closed.
Non-sterile Surgical file
Operation Theatre
Class AA manually operated, hand-held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues.
Non-sterile Surgical forceps
Operation Theatre
Class AA surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues.
Non-sterile Surgical probe
Operation Theatre
Class AThe device is used to explore sinuses, fistulae, and other cavities and wounds.
Non-sterile Surgical punch
Operation Theatre
Class AA surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc.
Operating room shoes cover, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringIntended to be worn by operating room personnel during surgical procedures to protect foot of both the surgical patient and the operating room personnel from transfer of micro-organisms, body fluids, and particulate material.
Operating table traction frame
Operation Theatre
Class ANon-sterile, non-measuringIntended to position, support and/or distract the patient’s hand, wrist, forearm and arm in a variety of surgical procedures including, but not limited to arthroscopic or Orthopedic surgery.
Operation table system
Operation Theatre
Class AA complete surgical table system intended change the patients position and enable attaching various table accessories that aid in surgery.
Operation theatre pendant
Operation Theatre
Class ANon-sterile, non-measuringIntended to provide ergonomic solution for the positioning and management of medical devices, equipment, and utilities during surgeries and other medical interventions. It does not have additional functional uses.
Orthopaedic Shoulder Surgical Instrument Set
Operation Theatre
Class BA set of invasive surgical instruments to support various shoulder procedures, including shoulder arthroplasty, reconstruction, and related orthopaedic interventions, by enabling accurate placement and handling of implants and/or tissues as per the surgical technique. It does NOT contain orthopedic implants.
Patient anatomy model for surgical planning
Operation Theatre
Class ANon-sterile, non-measuringA model of the bone of a specific patient intended for use to facilitate accurate preoperative planning and introperative placement of a device during orthopaedic surgical procedures.
Patient gown, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringIntended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office).
Percutaneous Conduction Tissue Ablation
Operation Theatre
Class DClinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated.
Pneumoperitoneum Simple Needle
Operation Theatre
Class BInserting a Veress needle through the abdominal wall inside the peritoneal cavity.
Polymeric Surgical Mesh
Operation Theatre
Class CThe polymeric mesh comprises an absorbable polymeric fibre and a non-absorbable polymeric fibre knitted together to form an interdependent, co-knit mesh structure.
Powered general- purpose operation table
Operation Theatre
Class ANon-sterile, non-measuringA completely mobile surgical table (general-purpose) that has been improved to make it useable for almost all parts of the body that require surgery. Electrically line or battery operated.
Pressure Infusor Bag, non-measuring
Operation Theatre
Class ANon-sterile, non-measuringA non-powered, non-invasive bag intended to contain and apply pressure to a sealed bag of sterile fluid (e.g., IV bag, etc.) to assist in the infusion of fluid. It is not intended to connect to any active medical device. It does not administer, measure, monitor, or control the delivery of fluid. It has a pressure gauge for pressure measurement and inflation of only the bag. This is a single-use device.
Radial Surgical Retractor
Operation Theatre
Class BA sterile device intended to be inserted across a surgical incision to separate the margins of the incision to create a conduit to the underlying organs/tissues during hand-assisted minimally-invasive and open surgery. It may have accessory seal caps and/or channels/tubings to allow wound irrigation. This is a single-use device.
Radio Frequency (RF) Generator
Operation Theatre
Class CIntended for general use in electrosurgical coagulation of tissue.
Radiofrequency Ablation Device
Operation Theatre
Class DA medical procedure in which part of the electrical conduction system of the heart, tumour or other dysfunctional tissue is ablated using the heat generated from high frequency alternating current.
Retracting and Exposing Surgical instruments
Operation Theatre
Class AThese are transient use invasive surgical instruments, intended to hold back, or retract organs and tissue, or other article to have access to the operative area during surgical procedure. They spread open the skin, ribs and other tissues and are also used separate the edges of a surgical incision.
Retractor holder, reusable
Operation Theatre
Class ANon-sterile, non-measuringIntended for mounting of surgical retractors.
Retractor, abdominal, reusable
Operation Theatre
Class ANon-sterile, non-measuringA surgical instrument intended for separating the edges of an abdominal incision to expose or access organs or tissues to permit examination or intervention. This is a reusable device intended for transient use only.
Retractor, laminectomy, reusable
Operation Theatre
Class ANon-sterile, non-measuringA reusable, manual surgical instrument intended to separate the margins of an incision to permit excision of the lamina of the vertebral posteria arch. This is a reusable device intended for transient use only.
Reusable Surgical file
Operation Theatre
Class ANon-sterile, non-measuringA manually operated, hand-held surgical instrument intended to smooth out, grind off, or sever tissues. This is a reusable device intended for transient use.
Rib rongeur, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut and shorten rib bones, and round the rib stumps, during a surgical intervention. This is a reusable device.
Robot-assisted Endoscopic Surgery System
Operation Theatre
Class CAn assembly of electromechanical devices intended to be used during computer-assisted surgery (CAS) intended to to hold, maintain in a desired position, and enable positional adjustment of endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use) (master-stave telemanipulation), for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA), etc.). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. It may be used in various surgical specialties including cardiac interventions.
Robotic electrosurgical instrument, bipolar, reusable
Operation Theatre
Class CA reusable electrosurgical device intended to be connected directly to the arm of a robotic surgical system [not included] to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator [not included] directly to tissues for cutting/coagulation/ablation/retraction during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery.
Robotic electrosurgical instrument, monopolar
Operation Theatre
Class CAn electrosurgical device intended to be connected directly to the arm of a robotic surgical system [not included] to deliver electrosurgical current in a monopolar configuration (i.e., with a return electrode) from a generator [not included] directly to tissues for cutting/coagulation/ablation, etc. during robotic surgery. This may be a reusable or single-use device.
Robotic Surgical Irrigation/Aspiration Cannula
Operation Theatre
Class BAn invasive component of a surgical suction/irrigation unit [not included] intended for use in connection with a compatible robotic surgical arm [not included] for delivering fluid to the surgical site and for evacuation and aspiration of fluids. It may also be used for tissue manipulation (retraction, dissection, etc.). It may include tubing sets, clamps. It may be a reusable or single-use device.
Robotic Surgical Scissors, endoscopic
Operation Theatre
Class BA non-electrosurgical device intended to be used in conjunction with a robotic surgical system [not included] to cut tissue or sutures during a robotic endoscopic procedure. This may be a reusable or single-use device.
Robotic surgical system arm-instrument connector/adaptor, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringAn adaptor intended to function as a connecting, electromechanical interface between a robotic surgical system articulated arm [not included] and an attached surgical instrument [not included]. This is a reusable device supplied non-sterile.
Sacroiliac joint transarticular fixation/ Arthrodesis kit, reusable
Operation Theatre
Class ANon-sterile, non-measuringA collection of hand-held, manual, non- measuring surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool. The implant(s) is not included. This is a reusable device intended for transient use.
Scalp clip applier, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manually-operated, surgical instrument intended for the application (the attachment) of nonimplantable, single-use scalp clips (not included) to the margins of a scalp wound/incision during a surgical intervention on the cranium/scalp. This is a reusable device.
Scalp clip forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manually-operated, surgical instrument intended to manually apply and remove haemostatic scalp clips (not included) from the scalp during or after a surgical intervention on the cranium/scalp. This is a reusable device.
Scalpel blade
Operation Theatre
Class BA blade intended to be attached to the handle of scalpel.
Scalpel blade remover, non- sterile
Operation Theatre
Class ANon-sterile, non-measuringIntended to assist the removal of used/blunt blades from a scalpel handle during a surgical procedure.
Scalpel, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to manually cut or dissect tissue. This is a reusable device intended for transient use.
Scissors, general-purpose, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use it might in addition be intended for cutting materials associated with surgery (e.g., sutures). This is a reusable device. Not intended for direct contact with central circulatory/central nervous system.
Scissors, suture, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held surgical instrument used during surgery to cut suture or ligature material, i.e., to divide lengths or remove excessive/unwanted ends. It is not a dedicated ophthalmic device. This is a reusable device.
Scissors, thoracic, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut tissue located in the thoracic cavity. This is a reusable device intended to be sterilized prior to use.
Sclerotherapy Needle/Catheter
Operation Theatre
Class BIt is designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic
Screw extractor, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical tool intended to remove damaged implanted screws. This is a non-measuring, reusable device intended for transient use.
Self-retaining surgical retractor, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-operated, self-retaining, surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery it is not intended to retract the ribs and is not dedicated to ophthalmic surgery. This is a reusable device intended for transient use only.
Skin marker guide
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile device intended to be used as a guide to create markings on the skin surface with a drawing skin marker, typically to outline a surgical incision site or for dermatology applications.
Skin marking transfer paper
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile, non-invasive device intended to transfer a grid of ink dots onto the skin surface to assist a clinical procedure. This is a single-use device.
Skin staple remover, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used to remove skin staples from a wound or incision that no longer requires stapling to stay closed. This is a reusable device.
Soft Tissue Repair Material Anchor, bioabsorbable
Operation Theatre
Class DA bioabsorbable device intended to be anchored into soft tissues/tendons, to serve as a site of attachment for surgical mesh or sutures using a delivery device; it is neither intended to anchor soft tissues to bone nor repair cartilage. This may be supplied standalone or prefilled in a delivery device. It is not a dedicated suture fastener. This is a sterile, single-use device.
Soft-tissue surgical forceps, alligator/ Alligator forceps/Crocodile forceps, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to facilitate grasping and manipulation of soft- tissues/anatomical structures it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. This is a reusable device intended to be sterilized prior to use.
Soft-tissue surgical forceps, scissors-like, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual, open-surgery instrument intended to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels) it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. This is a reusable device intended to be sterilized prior to use.
Soft-tissue surgical forceps, tweezers-like, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual, open-surgery instrument intended to facilitate grasping and manipulation of soft-tissues. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.
Soft-tissue Ultrasonic Robotic Surgical Instrument
Operation Theatre
Class CA sterile component of an ultrasonic surgical assembly intended to be connected directly to the arm of a robotic surgical system, and convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end for soft-tissue manipulation (dissection, back cutting, coagulation, etc.) upon contact during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery.
Soft-Tissue Ultrasonic Surgical System Handpiece
Operation Theatre
Class CA hand-held component of an ultrasonic surgical system, intended for use in conjunction with a removable ultrasonic tip [not included], intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for the tip placed at its end to mechanically/thermally fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. This is not intended for cardiac/neurosurgeries. This may be a reusable/single-use device.
Soft-Tissue Ultrasonic Surgical System Instrument
Operation Theatre
Class CA hand-held component of an ultrasonic surgical system, including an ultrasonic handpiece and removable tip, intended to convert high frequency electrical current from a generator into an ultrasonic oscillation and make contact with a patient while oscillating (vibrating) at high frequency for the purposes of soft-tissue cell fragmentation, heat ablation, cutting and/or coagulation, etc. during open- or endoscopic surgery. This may be a reusable/single-use device.
Sterile Applicator for Adhesive/Sealant/Haemostatic Powder
Operation Theatre
Class BAn empty sterile applicator intended for the controlled application of a surgical adhesive/sealant/Haemostatic Powder during surgical procedures for various haemostatic and/or tissue bonding uses. It typically consists of an applicator (e.g., dropper, spreader) for use with a single-component syringe; it may include the syringe and additional devices to assist extraction of the adhesive/sealant from a bottle. This is a single-use, sterile device.
Sterile Blood vessel surgical stripper
Operation Theatre
Class BA surgical instrument used for complete or partial vascular resection.
Sterile Hemostatic clip applier
Operation Theatre
Class BA surgical device designed to apply a hemostatic clip for ligation of a blood vessel.
Sterile Scalpel
Operation Theatre
Class BAn instrument used to sever and separate body tissues during surgery.
Sterile Staple remover
Operation Theatre
Class BA metal or plastic surgical instrument used to remove staples from a surgical wound or incision that no longer requires stapling to stay closed.
Sterile Surgical file
Operation Theatre
Class BA manually operated, hand-held surgical instrument with a series of bumps or teeth on its surface that is used to smooth out, grind off, or sever tissues.
Sterile Surgical forceps
Operation Theatre
Class BA surgical or dental device that is used to clamp and sever the cartilage, bone and other hard tissues.
Sterile Surgical probe
Operation Theatre
Class BThe device is used to explore sinuses, fistulae, and other cavities and wounds.
Sterile Surgical punch
Operation Theatre
Class BA surgical instrument used to create a hole for suturing or anastomosis of a tissue, blood vessel, etc.
Suction Ablation Catheter System
Operation Theatre
Class DIntended for use in inactivating portions of the heart's conduction system to prevent abnormal heartbeat rates, comprises a tubular body having an open, distal end and a proximal aperture for applying suction through the catheter and through the distal end.
Suction system filter, non- sterile
Operation Theatre
Class ANon-sterile, non-measuringA filter intended to be used with a suction system to separate tissue from the fluid waste collected from a medical procedure. Not intended for collection/separation of allografts.
Suction system operated by vacuum
Operation Theatre
Class AA device used for such treatment as the aspiration of liquid or granular substances by using negative pressure supplied by the hospital's medical gas supply system at bed side for using on patient.
Suction system portable, Electrical/Pneumatic
Operation Theatre
Class AA device that generates negative pressure used for such treatment as the aspiration of liquid or granular substances.
Suction Tip and Catheter
Operation Theatre
Class BSuction Catheters feature a whistle tip and a thumb control port for precise and accurate suctioning.
Suction/irrigation system canister/bottle holder
Operation Theatre
Class ANon-sterile, non-measuringA device intended to be used to hold a dedicated fluid or collection/specimen canister or bottle (not included) that is used within a suction and/or irrigation system. This is a reusable device.
Surgeon Chair
Operation Theatre
Class ANon-sterile, non-measuringIntended to be occupied by a surgeon in a seated position during surgical procedures to provide the surgeon with support for the back and arms. May be electric and adjustable.
Surgical Absorbent Sponge
Operation Theatre
Class BA sterile, single-use sponge made of absorbent material (e.g., cotton twill, etc.) intended for absorbing blood and other fluids during surgery to keep the operative field clear. It may have radiopaque markers. This is a single-use device.
Surgical apparel, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringIntended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate.
Surgical binoculars, reusable
Operation Theatre
Class ANon-sterile, non-measuringIntended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention.
Surgical camera holder
Operation Theatre
Class ANon-sterile, non-measuringIntended to hold and position a camera, or camera system and/or other devices during surgical procedures.
Surgical cap, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringIntended to protect face of patient and the operating room personnel from the transfer of micro-organisms, body fluids & particulate material.
Surgical Dilator, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for enlarging cavities or openings during surgical procedures. This is not intended to be be used on central-circulatory or/and central nervous system. This is a reusable device, intended for transient use.
Surgical dissector, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to separate a soft tissue or body structure from another. This is a reusable device intended for transient use.
Surgical guillotine, reusable
Operation Theatre
Class ANon-sterile, non-measuringIntended for severing tissue as a means to prevent infection/drainage of infected site. This is a reusable device.
Surgical hair clippers
Operation Theatre
Class ANon-sterile, non-measuringA hand-held electrically-powered device intended for removing long hair from the head or body of a patient prior to surgery/treatment. The device is typically operated by a healthcare professional. This is a reusable device.
Surgical hair clippers blade
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile cutting component of powered surgical hair clippers intended for removal of long hair from the head or body of a patient prior to surgery/treatment. This is a single-use device.
Surgical hair clippers suction system
Operation Theatre
Class ANon-sterile, non-measuringAn assembly of devices intended to be used in conjunction with hair clippers (not included) to remove cut hair through suction, typically as part of hair removal prior to surgery.
Surgical hair clippers suction system tubing set
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile length of flexible tubing and associated items intended to be used with surgical hair clippers as a component of a surgical hair clippers suction system, during removal/collection of cut hair through suction, typically as part of hair removal prior to surgery.
Surgical helmet system, non- sterile
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile system intended for the purpose of protecting healthcare workers and patients from cross-infection during surgery. It may have a power-supply and battery pack to drive internal ventilation. It does not contain sterile, disposable items.
Surgical helmet, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringA non-powered device intended to be worn by operating room personnel (the surgeon or assisting doctors/nurses) during a surgical procedure to protect them from the transfer of microorganisms, body fluids, and particulate material which may inadvertently come into contact or splash into their face. This is a reusable device.
Surgical implant handling forceps
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to grasp and manipulate a surgical implant (excluding sutures) during implantation it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. This is a reusable device intended to be sterilized prior to use.
Surgical instrument assist arm system
Operation Theatre
Class ANon-sterile, non-measuringThe device is intended to assist in maintaining spatial positioning of instruments during surgical procedures.
Surgical instrument containment holder, single- use, non-sterile
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury.
Surgical instrument guard, reusable
Operation Theatre
Class ANon-sterile, non-measuringIt is a reusable, non-sterile, non-invasive, non-active accessory intended to preserve the integrity of instrument tips and the cannula seal during insertion and removal.
Surgical instrument handle, non-torque-limiting
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw, reamer, dental implant, mucotome, or soft-tissue coring punch it does not include a torque-limiting function. This is a reusable device.
Surgical instrument holder, reusable
Operation Theatre
Class ANon-sterile, non-measuringA device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s).
Surgical instrument interim- placement holder, reusable
Operation Theatre
Class ANon-sterile, non-measuringA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury).
Surgical instrument rack
Operation Theatre
Class ANon-sterile, non-measuringIntended for the safe storage and counting of used sharps during and prior to the the end of a surgical procedure. The used sharps may be held in place by foam, magnet or other mechanisms and the device can be closed securely for safe sharps disposal.
Surgical knee cover
Operation Theatre
Class ANon-sterile, non-measuringReusable surgical cover intended to be used as a protective cover to protect the patella during knee surgery.
Surgical lens (camera accessory)
Operation Theatre
Class ANon-sterile, non-measuringA device intended to be used with a camera, or a camera system being used during medical procedures.
Surgical light system
Operation Theatre
Class AAn illuminator device intended to providing optimial light and colour rendering to aid in performing surgery.
Surgical light/illumination system/OT lights
Operation Theatre
Class ANon-sterile, non-measuringIntended to providing optimal light and colour rendering to aid surgery. This does not have a measuring function.
Surgical mallet head, reusable
Operation Theatre
Class ANon-sterile, non-measuringA device intended to replace the head of some types of surgical mallets and hammers. This is a reusable device.
Surgical mallet/Surgical hammer, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It may also be used for autopsy. This is a reusable device.
Surgical material compression device, reusable
Operation Theatre
Class ANon-sterile, non-measuringA reusable manual instrument intended to flatten material, such as tissue, for use in a surgical procedure (e.g., tympanoplasty) after it has been flattened.
Surgical Mist Irrigation Device
Operation Theatre
Class BA device, consisting of an irrigation tip and tubing, intended to deliver a combined stream of air/gas and mist to clear blood and improve the visualization of a surgical site. This is a single-use device
Surgical probe, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to explore sinuses, fistulae, and other cavities and wounds. This device is not intended to be connected to active device and does not have additional functional uses. This is a reusable device.
Surgical Punch/Bone Punch, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. This is a reusable device intended for transient use.
Surgical Retractor system blade, reusable
Operation Theatre
Class ANon-sterile, non-measuringA component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system intended to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. This is a reusable device. It is intended for transient use.
Surgical Retractor system, self-retaining
Operation Theatre
Class ANon-sterile, non-measuringAn assembly of surgical instruments/devices intended to be used to create a self-locking, self- retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery it is not intended for neurosurgery/cardiac surgery, or ophthalmic surgery. This is a reusable device intended for transient use.
Surgical robot unit
Operation Theatre
Class BAn operation support device used in open surgery or endoscopic surgery that performs treatment of tissues including suturing, detaching and severing, and installing a prosthesis.
Surgical screwdriver, reusable
Operation Theatre
Class ANon-sterile, non-measuringA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw,etc.) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). This is a non- measuring, reusable device intended for transient use. It is not intended to be connected to an active device.
Surgical Sealant
Operation Theatre
Class BFor use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Surgical sleeve cover, non- sterile
Operation Theatre
Class ANon-sterile, non-measuringIt is a forearm covering intended to be worn over a scrub suit by healthcare staff during procedures to maintain hygiene and prevent cross- contamination of microorganisms, body fluids, and particulate materials between the patient and staff.
Surgical Smoke Evacuation System Tubing
Operation Theatre
Class AA sterile non-invasive component of a surgical smoke evacuation system, intended to capture, conduct, and exhaust the smoke generated during various surgical procedures (e.g., electrocautery, electrosurgical diathermy device, etc.). It may have a filter for entrapping hazardous particulates/microbes from the surgical smoke. It is not intended to channel/aspirate body fluids. This is a single-use device.
Surgical Staples
Operation Theatre
Class BSurgical staples are specialized staples used in surgery in place of sutures to close skin wounds, connect or remove parts of body during surgery.
Surgical Support Kit, single-use
Operation Theatre
Class BA collection of sterile personal protective equipment (surgical gloves, masks and gowns) and other non-powered, assistive accessories (such as surgical trays, gauze, surgical drapes, etc.) intended to be worn or used by surgeons and other medical professionals during surgical interventions. This does not include surgical instruments. This is a single-use device.
Surgical traction tensioner connector
Operation Theatre
Class ANon-sterile, non-measuringA connecting/extension device intended to be fastened between a surgical traction tensioner/rod/cord and a patient-contact traction device (e.g., orthopaedic bone wire, foot boot, hand wrap/trap) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis). It is intended to be used during orthopedic surgery. This is a reusable device.
Surgical video camera
Operation Theatre
Class ANon-sterile, non-measuringA video camera intended to generate video images of surgical procedures, which are fed to a monitor screen for local or external viewing. This does not have a measuring function.
Surgical/emergency suction handle
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile, noninvasive, non-powered, hand- held device intended to be connected to, and facilitate manipulation of, an appropriate cannula/tip (not included) for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction it is not intended for irrigation. It does not incorporate switch, valves, or buttons.
Suture Anchor (Spartan PEEK Suture Implant)
Operation Theatre
Class CSoft Tissue Repair
Suture Knot Pusher, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for use during an internal suturing procedure to advance suture knots created extracorporeally to the point of appropriate suture tension. This is not intended for use in direct contact with the central circulatory/central nervous system. This is a transient-use, reusable device intended to be sterilized prior to use.
Suture Needle, reusable
Operation Theatre
Class ANon-sterile, non-measuringA non-sterile instrument intended to be used to insert and pull suture material (not included) through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. This is a reusable device intended to be sterilized prior to use.
Suturing Needle holder, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. This is a reusable device.
Suturing Unit, non-powered
Operation Theatre
Class ANon-sterile, non-measuringA non-powered, hand-held device intended to pass sutures (not included) or a needle/suture assembly (not included) through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. This is a reusable device.
Tenotome, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut a tendon. This is a reusable device intended for transient use.
Thermal Ablation Device
Operation Theatre
Class CDestruction of tissue by application of heat. Ablation of the endometrium as a treatment for menorrhagia is performed by placing a balloon filled with hot water in the uterine cavity.
Tissue adhesive for non-topical use
Operation Theatre
Class DIntended for use in adhesion of internal tissues and vessels, for example adhesives used in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery.
Tissue adhesive for the topical use
Operation Theatre
Class CIntended for topical closure of surgical incisions including laparoscopic incisions and simple traumatic lacerations.
Tongue depressor, surgical
Operation Theatre
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. The device is generally used in oral surgery (e.g., during tonsillectomy). This is a reusable device.
Torque Wrench, reusable
Operation Theatre
Class ANon-sterile, non-measuringA manually operated surgical instrument intended for gripping, turning or twisting ,loosening, etc. of an object, e.g., a nut, wire, etc. This is a non- measuring, reusable device.
Ulnar/brachial nerve protector
Operation Theatre
Class ANon-sterile, non-measuringA non-powered, non-invasive device intended to provide cushioning, support and protection to elbow and arms during prolonged surgeries.
Ultrasonic Orthopaedic Cement Extractor
Operation Theatre
Class BA powered assembly of devices intended for the application of ultrasonic energy to fragment and extract bone cement during an orthopaedic surgical procedure (e.g., arthroplasty revision, etc.) without incising bone. It may include an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove cement, and connecting cables. This is NOT intended for cutting/ablating bone or tissues
Vein Ablation Device
Operation Theatre
Class CIt is a non-thermal, minimally-invasive choice for treating the source of varicose veins, providing patients with immediate recovery and a return to normal daily routines.
Vein stripper, reusable
Operation Theatre
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. This is a reusable device.
Vice grip, reusable
Operation Theatre
Class ANon-sterile, non-measuringIntended to hold pliers during surgical procedures. This is a reusable device.
Warming high-flow infusion pump
Operation Theatre
Class CA device to be used for heating and rapidly infusing blood or other fluids during surgical procedures involving major bleeding, or for burns or injuries.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
Other categories
- Anesthesiology
- Cardiovascular
- Dental
- Dermatological and Plastic Surgery
- ENT
- Gastroenterology
- General Hospital
- General Hospital/Orthopedics
- Interventional and Radiology
- Nephrology and Renal Care
- Neurological
- Obstetrical and Gynecological
- Oncology
- Ophthalmic
- Ophthalmology
- Pain Management
- Pediatrics and Neonatology
- Personal Protective Equipment
- Physical Support
- Radiotherapy
- Rehabilitation
- Respiratory
- Software
- Urology