CDSCO risk classification
Gastroenterology medical device classification
Every gastroenterology device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 35 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 216
- Class A
- 47
- Class B
- 130
- Class C
- 37
- Class D
- 2
Gastroenterology devices and their class
216 devices
Absorbent enteric stomal dressing
Gastroenterology
Class BTo be placed over a continent enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained from the intestines) to protect it from harmful external influences, which includes absorbent materials intended to protect the surrounding skin from enteric fluids.
Anal fistula circular cutter
Gastroenterology
Class BTo be intended for the circumferential resection of tissue to treat simple anal fistula.
Anal fistula seton
Gastroenterology
Class CA sterile implantable cord intended to be placed through an anal fistula tract and tied outside the fistula, forming a loop around the anus, to allow drainage through the fistula for tissue healing.
Anastomosis Bypass Tube
Gastroenterology
Class CIt is anchored to mucosa and submucosa 3 centimetres proximal to a site of colonic anastomosis and later spontaneously evacuated by way of the rectum.
Anoscope, reusable
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum.
Anoscope, single-use
Gastroenterology
Class BA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum.
Balloon dilators for Gastroenterology
Gastroenterology
Class CUsed to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.
Barium enema catheter
Gastroenterology
Class BA flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area.
Bile duct prosthesis
Gastroenterology
Class CAn implantable artificial substitute for the tube-like structure that carries bile from the gallbladder to the duodenum.
Biliary manometric catheter
Gastroenterology
Class BA sterile, non-electrical flexible tube intended to be inserted into the biliary tree to measure pressures within the ducts, especially to evaluate sphincter of Oddi function.
Biliary stents
Gastroenterology
Class CBiliary stents provide bile drainage from the gallbladder, pancreas and bile ducts to the duodenum in conditions such as ascending cholangitis due to obstructing gallstones.
Biliary stone retrieval basket
Gastroenterology
Class BIntend to extract stones in an antegrade fashion through an ampullary orifice previously treated by endoscopic sphincterotomy or less commonly with balloon dilation.
Catheter-balloon inflator, reprocessed
Gastroenterology
Class BA sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.It is typically used during angiography, angioplasty, gastrointestinal (GI), or sinuplasty procedures.
Catheter-balloon inflator, reusable
Gastroenterology
Class BA device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.
Catheter-balloon inflator, single-use
Gastroenterology
Class BA sterile device designed to manually inflate and regulate the pressure of a balloon catheter (e.g., by injecting and aspirating fluid or air within the balloon), and to deflate the balloon during a medical procedure.
Cholangiography Catheter
Gastroenterology
Class BDiagnostic evaluation of the bile ducts during laparoscopic cholecystectomy procedures.
Cholangiography Needle
Gastroenterology
Class BThe aspirating needle is passed through the patients skin and liver tissue until the tip penetrates one of the hepatic ducts.
Cholangiopancreatography catheter, reusable
Gastroenterology
Class BA flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP).
Cholangiopancreatography catheter, single-use
Gastroenterology
Class BA flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, intended for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP).
Closed-ended intestinal ostomy bag, multiple-piece
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed].
Closed-ended intestinal ostomy bag, one-piece
Gastroenterology
Class AA non-sterile plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed].
Colon Tube
Gastroenterology
Class BColon Tubes also called "Tips" or even Catheters are inserted from the anus, through the rectum to deliver your enema solution into the colon (large intestine).
Colonic endoscopy cuff
Gastroenterology
Class BA sterile distal attachment to a flexible endoscope intended to improve endoscopic control and bowel visualization during colonic endoscopy.
Colonic lavage kit, surgical
Gastroenterology
Class BA collection of sterile devices intended to be used during open colorectal surgery (bowel resection) to irrigate the colon above (proximal to) the site of a lesion/blockage, prior to surgical anastomosis, when preoperative preparation of the colon has not been possible, normally due to obstruction.
Colonic mucosa barrier dressing
Gastroenterology
Class CA non-sterile solution/suspension intended to be introduced into the sigmoid/descending colon as an enema for the treatment of inflammatory bowel disease (e.g., ulcerative colitis). It is intended to create an adhesive physical barrier on the colonic mucosa to protect the mucosa from potentially harmful substances in the distal colon lumen
Colonic stent
Gastroenterology
Class CA colonic stent is a flexible, hollow tube designed to keep a segment of the colon (large bowel) open when it has become blocked (obstructed). This blockage is commonly caused by a tumour inside the bowel or by outside pressure on the bowel wall.
Colonoscope positioning sleeve
Gastroenterology
Class BA non-sterile endoscopic sheath with two inflatable balloons designed to be mounted on a colonoscope to position and stabilize the endoscope within the large intestine of a patient.
Colonoscope stiffener
Gastroenterology
Class BA dedicated stiff wire that is inserted into a flexible colonoscope to allow the physician to increase the stiffness of the colonoscope when extra rigidity is required during a colonoscopy.
Colorectal sizer
Gastroenterology
Class BA hand-held manual surgical instrument designed to assess colon and/or rectal lumen diameter to aid the selection of an appropriate size intraluminal stapler (i. e, the stapler head) for bowel anastomosis following transection.
Colostomy Irrigation Kit, reusable
Gastroenterology
Class ANon-sterile, non-measuringA set of non-sterile, non-powered devices intended to administer lukewarm water through a colostomy stoma into the colon in a controlled, gravity-assisted manner, to facilitate bowel evacuation and bowel management in colostomy patients. It typically includes a colostomy irrigation bag, a flow regulator, a cone-shaped irrigation nozzle/tip, tubings and other non-powered accessories (irrigation sleeve, clamps, etc.). It is not intended for use in connection with any active medical device. Not for continuous use. This is a reusable device after appropriate cleaning.
Common bile duct dilator
Gastroenterology
Class BA hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts.
Connecting Tube
Gastroenterology
Class BUsed to provide connection to a drainage bag.
Decompression Tube
Gastroenterology
Class BDecompression using a rectal tube may assist in the treatment only if the sigmoid colon is involved.
Double Lumen for intestinal Decompression and/or Intubation Tube
Gastroenterology
Class BTracheal intubation, usually simply referred to as intubation, is the placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway or to serve as a conduit through which to administer certain drugs.
Duodenal bypass liner
Gastroenterology
Class CA non-sterile stent-like device with a valve designed to be implanted in the duodenum where it is intended to reduce duodenal nutrient absorption from food to facilitate obese patient weight loss.
Duodenal stents
Gastroenterology
Class CDuodenal Stent is indicated for the palliative treatment of gastroduodenal obstructions.
Duodenal-jejunal bypass liner
Gastroenterology
Class CA sterile stent-like implant designed to function as an impermeable barrier in the duodenum and part of the jejunum for partially-digested food from the stomach (chyme) passing on its inside and bile/digestive enzymes passing on its outside, intended to treat type 2 diabetes mellitus and obesity.
Endoscope calibration cover, reusable
Gastroenterology
Class ANon-sterile, non-measuringA plastic cap/cover intended to be placed onto the distal end of an endoscope (not included) to allow white balance and/or 3-D adjustment to be calibrated in the electronic control unit of the endoscope. This is a reusable device.
Endoscope channel cleaning valve
Gastroenterology
Class ANon-sterile, non-measuringAn adapter or valve to be fitted to an endoscope for cleaning purposes.
Endoscope cleaning brush
Gastroenterology
Class ANon-sterile, non-measuringA device intended to remove dirt or debris from the working channel (s) and irregular surface of the endoscope prior to disinfection and sterilization.
Endoscope collector
Gastroenterology
Class ANon-sterile, non-measuringA device intended to collect the excreted endoscopic video capsule camera.
Endoscope flushing adaptor
Gastroenterology
Class ANon-sterile, non-measuringAn adapter intended to be fitted to an endoscope air/water channel for flushing of the endoscope during post-procedural ‘precleaning’ step of endoscope reprocessing after endoscopic procedure.
Endoscope leak tester tubing
Gastroenterology
Class ANon-sterile, non-measuringIntended to deliver air or any other medium from a leak tester to the interior of an endoscope during a leak test.
Endoscope Patient Protection Distal Endcap, Single-Use
Gastroenterology
Class BAn invasive device, designed as a detachable cap, intended to cover the exposed distal end of an endoscope (e.g., duodenoscope, etc.) during an endoscopic procedure for patient safety. This is a sterile and single-use device.
Endoscope tissue removal cap
Gastroenterology
Class BA sterile plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue during electrosurgical treatment (e.g., for the treatment of Barrett’s oesophagus).
Endoscope/instrument holder, noninvasive, manually-adjusted
Gastroenterology
Class ANon-sterile, non-measuringA noninvasive, manually adjusted device intended to be used to hold, maintain in a desired position, and enable positional adjustment of an endoscope (e.g., laparoscope) and/or associated instruments/devices during an endoscopic examination/surgical procedure.
Endoscopic biopsy valve, non-sterile
Gastroenterology
Class AA non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Endoscopic biopsy valve, reusable
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Endoscopic biopsy valve, sterile
Gastroenterology
Class BA sterile device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Endoscopic cutting stapler connector
Gastroenterology
Class BA rod-like component of an endoscopic cutting stapler intended to enable connection between the stapler handpiece and the endpiece/loading unit.
Endoscopic electrosurgical biopsy/resection kit, full- thickness
Gastroenterology
Class CA collection of sterile devices, which includes an implantable haemostatic ligation clip, intended to be used to obtain a full-thickness tissue biopsy and/or therapeutic resection of gastric, duodenal, colonic, and/or rectal tissue during an endoscopic procedure.
Endoscopic electrosurgical biopsy/resection kit, partial-thickness
Gastroenterology
Class CA collection of devices designed to be inserted through a compatible endoscope to obtain a mucosal tissue biopsy and/or therapeutic resection of upper gastrointestinal (GI) tract tissue, typically during endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Endoscopic electrosurgical electrode/submucosal lift needle
Gastroenterology
Class BA sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation.
Endoscopic gastrointestinal stenosis dilator
Gastroenterology
Class BA sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization.
Endoscopic irrigation/aspiration foot- pedal
Gastroenterology
Class ANon-sterile, non-measuringA manual, foot-operated device intended to be used in conjunction with an irrigation tubing set (not included) to facilitate delivery of sterile irrigation fluid by displacing a syringe plunger (not included).
Endoscopic motorized cutting stapler, reusable
Gastroenterology
Class BA hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses.
Endoscopic motorized cutting stapler, single-use
Gastroenterology
Class BA sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses.
Endoscopic Needle
Gastroenterology
Class BUsed to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Endoscopic needleless submucosal lift catheter
Gastroenterology
Class BA sterile, flexible tube intended to non-invasively deliver a submucosal lifting solution into the submucosa of the gastrointestinal tract through a flexible endoscope during an endoscopic procedure (e.g., gastroscopy, colonoscopy) to lift a lesion, typically for subsequent excision.
Endoscopic overtube, reusable
Gastroenterology
Class BA tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy).
Endoscopic spray catheter
Gastroenterology
Class BA sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) to administer fluids (e.g., dyes for mucosal coloration) in spray form.
Endoscopic video image processor
Gastroenterology
Class ANon-sterile, non-measuringA unit intended to receive receive and process electronic video image signals sent from the endoscope (not included). It is not intended to control the endoscope. This is not an image analysis tool.
Enema bag
Gastroenterology
Class ANon-sterile, non-measuringIntended to be used to hold an enema solution for administration into the rectum.
Enema tip, reusable
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile device made with Hevea natural rubber latex (NRL) intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum.
Enema tube
Gastroenterology
Class AA non-sterile, length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum.
Enema tube, non-sterile
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum.
Enteral feeding tube clearing kit
Gastroenterology
Class BA collection of non-sterile compounds and devices intended to be used to prevent and/or remove, through biochemical action, an enteral formula clog in an in situ enteral feeding tube to maintain luminal patency.
Enteral feeding/decompression tube clearing stem
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and/or jejunostomy tube, used for feeding and/or decompression, to maintain luminal patency.
Enteral tube extension, non-sterile
Gastroenterology
Class BA non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration.
Enteral tube extension, sterile
Gastroenterology
Class BA sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration.
Enteric stomal shield
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile cap intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction).
Esophageal Balloon Catheter
Gastroenterology
Class BIntended for use in adult and adolescent populations
Esophageal Obturator
Gastroenterology
Class BInserted through a patients mouth to aid ventilation of the patient during emergency resuscitation by occluding obturator (blocking) the esophagus, thereby permitting positive pressure ventilation through the trachea.
Externally-propelled flexible video colonoscope
Gastroenterology
Class BA non-sterile endoscope with a highly flexible sleeve and distal tip intended for the visual examination of the entire adult colon [lower gastrointestinal (GI) tract].
Feeding Tube
Gastroenterology
Class BA feeding tube is a device that's inserted into your stomach through your abdomen. It's used to supply nutrition when you have trouble eating.
Fistula-repair biomatrix implant
Gastroenterology
Class DA sterile, bioabsorbable, animal-derived substance intended to be injected into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue.
Flatus tube, reusable
Gastroenterology
Class ANon-sterile, non-measuringA tube intended to be inserted through the anus to remove flatus and relieve distension in the rectum. This is a reusable device.
Flexible fibreoptic choledochoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD).
Flexible fibreoptic colonoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract].
Flexible fibreoptic duodenoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine).
Flexible fibreoptic enteroscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum).
Flexible fibreoptic gastroduodenoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct].
Flexible fibreoptic gastroscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach.
Flexible fibreoptic oesophagoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended the visual examination and treatment of the oesophagus.
Flexible fibreoptic pancreatoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas.
Flexible fibreoptic sigmoidoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum).
Flexible ultrasound colonoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract].
Flexible ultrasound duodenoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the duodenum (the first part of the small intestine).
Flexible ultrasound gastroduodenoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct].
Flexible video choledochoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD).
Flexible video choledochoscope, single- use
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the biliary tract and related ducts [e.g., common bile duct (CBD), cystic duct, pancreatic duct], and for the removal of gallstones.
Flexible video colonoscope, reusable
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract].
Flexible video colonoscope, single-use
Gastroenterology
Class BA sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract].
Flexible video duodenoscope, reusable
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine).
Flexible video duodenoscope, single-use
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the duodenum (the first part of the small intestine).
Flexible video enteroscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum).
Flexible video gastroduodenoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct].
Flexible video gastroscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach.
Flexible video oesophagoscope, reusable
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.
Flexible video oesophagoscope, single- use
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus.
Flexible video pancreatoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas.
Flexible video sigmoidoscope
Gastroenterology
Class BAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum).
Forceps, gallbladder, reusable
Gastroenterology
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to atraumatically grasp or manipulate the gallbladder. This is a reusable device intended for transient use.
Forceps, intestinal, reusable
Gastroenterology
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for the atraumatic holding/grasping and/or compression of intestinal structures, tissues, and some organs during a surgical procedure. This is a reusable device intended for transient use.
Gastric pH strip
Gastroenterology
Class ANon-sterile, non-measuringIntended to be used to indicate the pH level of human gastric aspirate.
Gastric sleeve
Gastroenterology
Class CA sterile implantable device intended to be wrapped around the proximal portion of the stomach to reduce stomach volume and facilitate weight loss in overweight/obese patients by attempting to restrict the quantity of food consumed through an increased sense of satiety (fullness).
Gastric tonometry catheter
Gastroenterology
Class BA sterile flexible tube intended for orogastric, nasogastric, or rectal insertion to sample carbon dioxide (CO2) from the mucosal vasculature of the stomach or sigmoid colon for the measurement of partial pressure (i.e., tonometry) of CO2 (pCO2) during diagnosis of mensenteric ischemia.
Gastric, Colonic, etc. Irrigation and Aspiration Catheter
Gastroenterology
Class BUsed for instilling fluids into withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract.
Gastro- Enterostomy Tube
Gastroenterology
Class BTube is placed through the abdominal wall into the stomach and then through the duodenum into the jejunum.
Gastro-oesophageal antireflux prosthesis
Gastroenterology
Class CAn implantable device introduced into the gastro- oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus.
Gastro-oesophageal pH/impedance catheter, non-sterile
Gastroenterology
Class BA non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions.
Gastro-oesophageal pH/impedance catheter, sterile
Gastroenterology
Class BA sterile flexible tube with an with an electrical conductor at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions.
Gastro-urological director
Gastroenterology
Class BA slender, rod-like surgical instrument made of metal, typically with groove running along the centre of it distal shaft and/or continuing with an elongated malleable wire loop, that is used to guide other devices or instruments into a selected intracorporeal location during a gastroenterological/urological (GU) procedure.
Gastro-urological probe
Gastroenterology
Class BA slender, rod-like, hand-held manual surgical instrument, typically made of flexible metal with a blunt bulbous tip, designed for exploring gastroenterological/urological (GU) structures during a GU procedure.
Gastro-urological scoop
Gastroenterology
Class BA heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure.
Gastro-Urology Needle
Gastroenterology
Class BIntended for gastroenterology biopsy.
Gastrointestinal anastomosis coupler, bioabsorbable
Gastroenterology
Class DAn implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached.
Gastrointestinal anastomosis coupler, non- bioabsorbable
Gastroenterology
Class CAn implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached.
Gastrointestinal catheter/endoscope tracking system
Gastroenterology
Class BA multicomponent assembly of mains electricity (AC-powered) devices designed for real-time visualization/navigation of a catheter and/or endoscope during insertion in the gastrointestinal tract, by detecting its position/movement within an electromagnetic (EM) field and displaying three- dimensional (3-D) virtual images on a monitoring screen.
Gastrointestinal endoscopic clip applier
Gastroenterology
Class BA device intended to be used in combination with a compatible flexible endoscope for the application of a gastrointestinal endoscopic clip(s) [not included] to the mucosal lining of the gastrointestinal (GI) tract for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects during an endoscopic procedure.
Gastrointestinal endoscopic clip cutter
Gastroenterology
Class CA sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip.
Gastrointestinal endoscopic clip cutter generator
Gastroenterology
Class CA portable, mains electricity (AC-powered) device intended to be used in conjunction with a cutter for the endoscopic removal of a gastrointestinal endoscopic clip.
Gastrointestinal endoscopic clip, long-term
Gastroenterology
Class CA sterile clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects.
Gastrointestinal endoscopic clip, short-term
Gastroenterology
Class BA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects.
Gastrointestinal Endoscopic Insufflator
Gastroenterology
Class BAn electrically-powered device intended to be used during an endoscopic procedure to distend (expand by pressure) the lumen of the colon or other portion of the gastrointestinal (GI) tract, and/or improve endoscopic visualization through the pressure-limited introduction of medical gas [e.g., carbon dioxide (CO2)]. This may also be referred to as a gas distension system.
Gastrointestinal manometric catheter, electronic
Gastroenterology
Class BA non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure it may additionally be intended to measure pH and electrical impedance and contain a lumen.
Gastrointestinal manometric catheter, non- electronic
Gastroenterology
Class BA non-sterile, non-electrical flexible tube intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract for measuring pressure to assess peristaltic motility in the GI tract (e.g., oesophagus, stomach) or rectal musculature and anal sphincter functions, typically in the evaluation of GI disorders [e.g., gastro-oesophageal reflux disease (GERD), faecal incontinence].
Gastrointestinal ostomy tube pocket
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile, noninvasive pouch designed to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient.
Gastrointestinal Tube
Gastroenterology
Class BA gastrostomy tube (also called a G-tube) is a tube inserted through the abdomen that delivers nutrition directly to the stomach.
Gastrojejunostomy tube
Gastroenterology
Class CA sterile, thin, flexible, hollow cylinder percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum. It is used to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect of the mouth, oesophagus, or stomach, or a neuromuscular condition that affects chewing and swallowing), and to provide drainage/decompression for the stomach when it is necessary to bypass a longstanding obstruction of the stomach outlet into the small intestine.
Gastrostomy aspiration system gravity set
Gastroenterology
Class CA collection of non-sterile devices designed as the external portion of a gastrostomy aspiration system intended to be used post-surgery by the patient after implantation of the stomach tube for the removal of a portion of stomach contents after meals, by aspiration, to achieve portion control and subsequently weight loss in a morbidly obese (bariatric) patient (≥ 18 years).
Gastrostomy aspiration system stomach tube
Gastroenterology
Class CA sterile, thin, flexible, hollow cylinder intended to be percutaneously implanted by endoscopic methods into the stomach of a morbidly obese (bariatric) patient (≥ 18 years) for the removal of a portion of stomach contents after meals by aspiration when used with a dedicated gravity kit that is the external portion of a gastrostomy aspiration system.
Gastrostomy T fastener
Gastroenterology
Class CA device intended to be inserted into the stomach percutaneously to appose the anterior gastric wall to the anterior abdominal wall, typically to facilitate the insertion of a percutaneous gastrostomy tube or for procedures requiring stabilization/fixation of hollow gastrointestinal (GI) structures.
Gastrostomy tube Y-piece connector
Gastroenterology
Class BA sterile connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube.
Gravity enema set
Gastroenterology
Class AA collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine.
Gravity enema set, non- sterile
Gastroenterology
Class ANon-sterile, non-measuringA set of non-sterile device intended to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine.
Implantable gastric clamp
Gastroenterology
Class CA sterile implantable device designed to isolate the lesser curvature segment of the stomach (magenstrasse) to reduce stomach volume and facilitate weight loss in overweight/obese patients through a reduction in food consumption based on an increased sense of satiety (fullness).
Implantable incontinence- control electrical stimulation system
Gastroenterology
Class CAn assembly of battery-powered devices intended to treat chronic disorders of the pelvis and lower urinary or intestinal tract, typically related to urinary and/or faecal incontinence, through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder.
Implantable peritoneal catheter holder
Gastroenterology
Class CA small, sterile, implantable device designed to secure a peritoneal or lumboperitoneal catheter in situ by suturing it to the abdominal fascia at the point of entry/exit.
Intestinal ostomy bag anti- adhesion device
Gastroenterology
Class AA non-sterile, noninvasive device intended to be applied to the inner surface of an intestinal ostomy bag to prevent opposing inner walls of the bag from sticking together (anti-pancaking).
Intestinal ostomy base plate
Gastroenterology
Class ANon-sterile, non-measuringThe base plate is intended to fix the ostomy bag and adhere to intact skin around the stoma.
Intestinal ostomy kit
Gastroenterology
Class AA collection of non-sterile devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure).
Intestinal ostomy support kit
Gastroenterology
Class ANon-sterile, non-measuringA collection of non-sterile devices (base plate, towels, scissors) intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure).
Intestinal splint
Gastroenterology
Class CA sterile rigid or flexible device intended to be implanted within the abdomen to stabilize a portion of the intestine, or to stabilize and protect an injured portion of the intestine.
Intestinal stoma shield/support belt
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile plate intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin.
Intestinal stoma shield/support belt, reusable
Gastroenterology
Class AA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin.
Intestinal stoma shield/support belt, single- use
Gastroenterology
Class AA non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin.
Intraluminal oesophageal retractor
Gastroenterology
Class BA sterile, hand-held manual surgical instrument intended to be inserted through an orogastric (or nasogastric) tube to mechanically divert the oesophagus away from the site of surgery during electrical treatments of the heart (e.g., cardiac ablation), to facilitate surgical site access and to help prevent injury to the oesophagus.
Invasive silicone sheet dressing
Gastroenterology
Class BA sterile, flat stretch of silicone elastomer intended for use as a short-term intra-abdominal dressing following abdominal surgery, when a re-exploration of the wound/abdomen is planned within a thirty day period. It is used to achieve temporary abdominal closure to avoid the complications of an open abdomen.
Jejunostomy Catheter
Gastroenterology
Class BUsed for intraoperative feeding jejunostomy
Laparoscopic cholangiography catheter/needle
Gastroenterology
Class BA sterile, flexible, single-lumen tube with a distal needle intended to puncture the neck of the gallbladder (Hartmann’s pouch) during laparoscopic cholangiography to allow injection of contrast media.
Laparoscopic grasping forceps, Non sterile
Gastroenterology
Class AA sterile, rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure.
Laparoscopic grasping forceps, sterile
Gastroenterology
Class BA rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure.
Laparoscopic swab forceps
Gastroenterology
Class BAn instrument designed to grasp a pledget swab at the distal end to obtain cytological specimens and/or to perform blunt dissection during gynaecologic and/or other (e.g., cholecystectomy) laparoscopic procedures.
Levine Tube
Gastroenterology
Class BUsed for the aspiration of gastric and intestinal contents and administration of tube feedings or medications.
Manual enema device
Gastroenterology
Class BA non-sterile device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis.
Manual enema device, reusable
Gastroenterology
Class BA device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis.
Manual rectal irrigation system
Gastroenterology
Class BA portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence.
Motorized laparoscopic forceps
Gastroenterology
Class BA mains electricity (AC-powered) motorized surgical instrument designed for grasping, mobilizing, and suturing tissues/vessels under direct or endoscopic visualization during a surgical procedure.
Multiple-Piece Ostomy Pouch
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile, non-invasive device intended to collect and contain body effluent from a surgically created stoma (e.g., urostomy, colostomy, ileostomy) or/and from abnormal skin openings, such as wounds or fistulas. This is a single-use device.
Nasoenteral tube
Gastroenterology
Class BA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes.
Nasogastric tube holder, intranasal
Gastroenterology
Class BA non-sterile, non-surgically invasive device intended to be used to secure a nasogastric tube to the nose of a patient to prevent displacement or removal of the tube.
Nasogastric tube holder, noninvasive, non-sterile
Gastroenterology
Class AA small, non-sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient.
Nasogastric tube holder, noninvasive, sterile
Gastroenterology
Class AA small, sterile, noninvasive device intended to be used to secure a nasogastric tube to prevent displacement or removal of the tube from the patient.
NasoGastric Tube/Ryles Tube
Gastroenterology
Class BIt is a special tube that carries food and medicine to the stomach through the nose. It can be used for all feedings or for giving a person extra calories.
Non-vascular catheter introduction set
Gastroenterology
Class BA collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter).
Oesophageal Blakemore Tube
Gastroenterology
Class BIt is a medical device inserted through the nose or mouth and used occasionally in the management of upper gastrointestinal hemorrhage due to oesophageal varices .
Oesophageal Sengtaken Tube
Gastroenterology
Class BIt is used only in emergencies where bleeding from presumed varices is impossible to control with medication alone.
Oesophageal temperature monitor
Gastroenterology
Class BAn electronic device used to monitor the temperature of the oesophagus during surgical ablation of the wall of the left atrium. It typically measures the oesophageal temperature at several adjacent levels, and displays these temperature values simultaneously to help the surgeon avoid the application of heat high enough to form atrial-oesophageal fistulas.
Ostomy adhesive
Gastroenterology
Class ANon-sterile, non-measuringAdhesive to be placed around stoma to attach two-piece ostomy collection device.
Ostomy odour-absorbent/deodorizer
Gastroenterology
Class ANon-sterile, non-measuringA device intended to be used with an ostomy pouch/bag to absorb unwanted odours and/or emit fragrance to conceal any unpleasant odours emanating from the patients stoma/ostomy devices and to facilitate emptying and cleaning of the pouch by helping the contents move more freely, and pouch management during routine ostomy care. After application, this device cannot be reused.
Paediatric-temperature nasogastric/orogastric tube
Gastroenterology
Class CA sterile, thin, flexible, hollow cylinder designed as a paediatric or neonatal enteral feeding tube with an integrated temperature sensor that continuously measures oesophageal temperature.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Pancreatic stent
Gastroenterology
Class CPancreatic duct stents are often placed in patients who have chronic pancreatitis.
Partially-implantable abdominal port/catheter
Gastroenterology
Class CA sterile partially-implantable device intended to provide access to the peritoneal cavity for infusion (e.g., insulin, chemotherapeutic agents).
Percutaneous biliary biopsy procedure kit
Gastroenterology
Class BA collection of sterile devices intended to be used to obtain a tissue specimen from within the biliary duct system for histological analysis by a percutaneous endoscopic approach, typically under fluoroscopic visualization.
Pharyngeal electrical stimulation catheter
Gastroenterology
Class CA sterile, flexible tubular device intended to deliver pharyngeal electrical stimulation for the treatment of neurogenic dysphagia.
Powered rectal/colostomy irrigation system
Gastroenterology
Class BA portable assembly of battery-powered devices intended to be used by, or on a patient, for the controlled introduction of a non-medicated solution (typically water) into the rectum to treat faecal incontinence or constipation (rectal irrigation), and/or for colostomy site irrigation.
Probiotic oropharyngeal mucosa dressing
Gastroenterology
Class CA non-sterile substance intended to be applied to the mucosa of the mouth and/or pharynx to facilitate saprophytic microflora colonization within the oral cavity/pharynx, typically following antibiotic therapy, bacterial infection, or injury. It includes probiotic bacteria (e.g., Streptococcus salivarius, Streptococcus oralis) and compounds that create a barrier to facilitate growth of the probiotic bacteria.
Proctoscope, reusable
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus.
Proctoscope, single-use
Gastroenterology
Class BA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus.
Rectal Balloon
Gastroenterology
Class BReducing the intrafraction motion and improving the sparing of rectal wall by reducing the rectal volume in the high- dose region, resulting in significant reduction in rectal toxicity.
Rectal Catheter
Gastroenterology
Class BIt is inserted into the rectum in order to relieve flatulence which has been chronic and which has not been alleviated by other methods.
Rectal dilator, reusable
Gastroenterology
Class ANon-sterile, non-measuringIntended to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function. This is a reusable device.
Rectal speculum
Gastroenterology
Class BA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened.
Rectal speculum, reusable
Gastroenterology
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.
Rectal suction biopsy system
Gastroenterology
Class BAn assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)].
Rectal Tube
Gastroenterology
Class BA rectal tube, also called a rectal catheter, is a long slender tube which is inserted into the rectum in order to relieve flatulence.
Rectal/colonic lavage support kit
Gastroenterology
Class AA collection of non-sterile, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon.
Rectoscope, reusable
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus.
Rectoscope, single-use
Gastroenterology
Class BA sterile endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus.
Rectoscope/proctoscope handle
Gastroenterology
Class ANon-sterile, non-measuringA manual device intended to be used as a handle to hold a rectoscope or proctoscope during an examination procedure.
Rectosocope/proctoscope handle end-cap
Gastroenterology
Class ANon-sterile, non-measuringA small cap intended to be fitted to the proximal end of the handle of a rectoscope or proctoscope during an examination procedure to provide an airtight seal so that air can be pumped through the scope to inflate the bowel.
Rigid oesophagoscope
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus.
Rigid sigmoidoscope
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum).
Robotic electrosurgical instrument, bipolar, single- use
Gastroenterology
Class CA sterile electrosurgical device intended to be connected directly to the arm of a robotic surgical system to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) from a generator directly to tissues for cutting/coagulation/ablation during robotic endoscopic (e.g., laparoscopic, arthroscopic) surgery.
Robotic surgical retractor
Gastroenterology
Class BA surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure.
Scissors, rectal, reusable
Gastroenterology
Class ANon-sterile, non-measuringA hand-held, manual instrument intended to cut tissue during rectal surgery. This is a reusable device intended for transient use.
Sclerotherapy Needle/Catheter
Gastroenterology
Class BSclerotherapy Needles are designed to provide access for injection therapy applications and may also be used for polypectomy and endoscopic mucosal resection (EMR).
Self-propelled flexible video colonoscope
Gastroenterology
Class BA sterile endoscope with a highly-flexible, self- propelled, inserted portion intended for the visual examination of the entire colon.
Spring-loaded pneumoperitoneum needle, reusable
Gastroenterology
Class BA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy.
Spring-loaded pneumoperitoneum needle, single-use
Gastroenterology
Class BA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy.
Static magnetic anal plug
Gastroenterology
Class BA non-sterile magnetic device designed to be inserted into the rectum by the user and retained there for a specified period of time (e.g., 1 to 2 hours per day for 10 to 20 days) to help reduce anal haemorrhoids with magnetism.
Stoma drainage catheter
Gastroenterology
Class BA sterile flexible tube that is inserted into a stoma (an artificial opening in the body, especially in the abdominal wall, made during a surgical procedure) to drain bodily waste from an internal stoma container normally directly into the toilet.
Stoma support implant
Gastroenterology
Class CA sterile, non-bioabsorbable device intended to be implanted into the abdominal wall during a gastro- urological ostomy procedure to reduce the risk of parastomal hernia by supporting the abdominal wall surrounding the stoma.
Stomach Evaculator (Gastric Lavage) Tube
Gastroenterology
Class BPassage of a tube via the mouth or nose down into the stomach followed by sequential administration and removal of small volumes of liquid.
Stone Retrieval ERCP Balloon Catheter, single-use
Gastroenterology
Class BA tubular, non-electrical device with an inflatable balloon, intended for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It may simultaneously enable the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.
TEM/TEO rectoscope, optical
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO).
TEM/TEO rectoscope, video
Gastroenterology
Class BAn endoscope with a rigid inserted portion intended for surgical treatment of the lower part of the bowel during transanal endoscopic microsurgery (TEM) or transanal endoscopic operations (TEO).
Thermal-regulation orogastric tube
Gastroenterology
Class CA non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression and 2) thermal regulation of the whole body via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature).
Transenteric drainage tube
Gastroenterology
Class CA sterile non-bioabsorbable tube intended to be endoscopically implanted transmurally between the gastrointestinal (GI) tract and a pancreatic pseudocyst or the biliary tract for drainage.
Transition (ENFit) Connector
Gastroenterology
Class ANon-sterile, non-measuringA non-sterile, single-use connector intended to facilitate the safe and secure connection between enteral feeding systems and legacy feeding tubes for the administration of enteral nutrition.
Video capsule endoscopy system
Gastroenterology
Class BAn assembly of electronic devices designed for the internal visualization and examination of sections of the gastrointestinal (GI) tract using a non-digestible video capsule after it has been swallowed by a patient.
Video capsule endoscopy system application software
Gastroenterology
Class BAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and analysis capabilities to a video capsule endoscopy system.
Video capsule endoscopy system capsule
Gastroenterology
Class BA non-sterile, battery-powered, electronic component device of a video capsule endoscopy system designed to be swallowed by a patient for the internal visualization and examination of the gastrointestinal (GI) tract.
Wire
Gastroenterology
Class CAn esophageal stent is a stent (tube) placed in the oesophagus to keep a blocked area open so the patient can swallow soft food and liquids.
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.
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