KNT · Class II · 21 CFR 876.5980

FDA Product Code KNT: Tubes, Gastrointestinal (and Accessories)

FDA product code KNT covers gastrointestinal tubes and accessories used for enteral feeding, gastric drainage, and bowel decompression.

These nasogastric, nasoenteric, and gastrostomy tubes are used to deliver nutrients and medications directly to the stomach or small intestine in patients who cannot eat orally, or to decompress the GI tract in obstruction and post-operative ileus.

KNT devices are Class II medical devices, regulated under 21 CFR 876.5980 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Biosearch Medical Products, Inc., Abbott Laboratories and Medical Innovations Corp..

651
Total
651
Cleared
152d
Avg days
1976
Since
651 devices
193–216 of 651
Cleared Feb 09, 1998
PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
K972478
Applied Medical Technologies
Gastroenterology & Urology · 223d
Cleared Jan 23, 1998
RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972025
Radius Intl., Inc.
Gastroenterology & Urology · 235d
Cleared Jan 23, 1998
RADIUS PUSH OVER THE GUIDE WIRE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K972102
Radius Intl., Inc.
Gastroenterology & Urology · 233d
Cleared Jan 22, 1998
RADIUS LOW PROFILE GASTROSTOMY TUBE KIT
K971901
Radius Intl., Inc.
Gastroenterology & Urology · 244d
Cleared Jan 12, 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891
Applied Medical Resources
Gastroenterology & Urology · 90d
Cleared Dec 19, 1997
AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
K973893
Applied Medical Technologies
Gastroenterology & Urology · 66d
Cleared Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554
Abbott Laboratories
Gastroenterology & Urology · 494d
Cleared Nov 07, 1997
LOW PROFILE FEEDING SET ACCESSORY
K971757
Applied Medical Technologies
Gastroenterology & Urology · 178d
Cleared Aug 15, 1997
ENTERAL NUTRITION 1000 ML/500ML
K970849
Medical Infusion Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Jul 21, 1997
CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
K970178
Corpak, Inc.
Gastroenterology & Urology · 185d
Cleared Jul 09, 1997
RPI DUAL PORT IRRIGATION ADAPTER
K964920
Ridge Products, Inc.
Gastroenterology & Urology · 212d
Cleared Jun 13, 1997
SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT
K971230
Innerdyne, Inc.
Gastroenterology & Urology · 72d
Cleared May 23, 1997
#ES-32 SUCTION CATHETER 32 FR.
K970890
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 18, 1997
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087
Sandoz Nutrition
Gastroenterology & Urology · 89d
Cleared Mar 14, 1997
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
K950017
Ross Products
Gastroenterology & Urology · 801d
Cleared Oct 04, 1996
COMPAT NASOJEJUNAL FEEDING TUBE
K961664
Sandoz Nutrition
Gastroenterology & Urology · 157d
Cleared Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113
Abbott Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 17, 1996
DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
K961345
Applied Medical Technologies
Gastroenterology & Urology · 162d
Cleared Sep 04, 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375
Boston Scientific Corp
Gastroenterology & Urology · 76d
Cleared Aug 29, 1996
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
K935512
Corpak Co.
Gastroenterology & Urology · 1017d
Cleared Aug 01, 1996
CATH CADDIE
K961884
Mark-Clark
Gastroenterology & Urology · 78d
Cleared Jun 05, 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 205d
Cleared May 21, 1996
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 188d
Cleared May 13, 1996
KANGAROO JEJUNAL FEEDING SYSTEM
K960677
Sherwood Medical Co.
Gastroenterology & Urology · 87d