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
121–144 of 651
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109
C.R. Bard, Inc.
Gastroenterology & Urology · 62d
Cleared Aug 27, 2010
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
K101199
Maquet Critical Care AB
Gastroenterology & Urology · 120d
Cleared Apr 22, 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273
Hollister, Inc.
Gastroenterology & Urology · 83d
Cleared Nov 23, 2009
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770
Coloplast A/S
Gastroenterology & Urology · 340d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759
Olympus Medical Systems Corporation
Gastroenterology & Urology · 94d
Cleared Feb 04, 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153
Hollister, Inc.
Gastroenterology & Urology · 103d
Cleared Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739
Boston Scientific Corp
Gastroenterology & Urology · 167d
Cleared Nov 25, 2008
ENTERAL ONLY EXTENSION SET
K082654
Respironics, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 13, 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598
C.R. Bard, Inc.
Gastroenterology & Urology · 175d
Cleared Mar 14, 2008
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K073034
Applied Medical Technology, Inc.
Gastroenterology & Urology · 140d
Cleared Dec 19, 2007
NON-IV ADAPTER FOR INFANT NG TUBE
K072756
Promedic, Inc.
Gastroenterology & Urology · 83d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476
Boston Scientific Corporation
Gastroenterology & Urology · 101d
Cleared May 23, 2007
GASTROSTOMY REPLACEMENT TUBE, MODEL 253
K070124
Degania Silicone , Ltd.
Gastroenterology & Urology · 127d
Cleared Feb 13, 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118
C.R. Bard, Inc.
Gastroenterology & Urology · 125d
Cleared Sep 11, 2006
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432
Hospira, Inc.
Gastroenterology & Urology · 110d
Cleared Apr 28, 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021
Conmedcorp
Gastroenterology & Urology · 15d
Cleared Nov 09, 2005
PEDIATRIC FEEDING TUBE
K052903
Promedic, Inc.
Gastroenterology & Urology · 26d
Cleared Nov 02, 2005
Y2K2 ENTERNAL TUBE FLUID FILTER
K051206
Moss Medical Products
Gastroenterology & Urology · 175d
Cleared Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551
Olympus Medical Systems Corporation
Gastroenterology & Urology · 15d
Cleared May 27, 2005
PROCON2
K042431
Incontinent Control Devices, Inc.
Gastroenterology & Urology · 261d
Cleared May 11, 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 174d
Cleared May 06, 2005
ANTI-I.V. ENTERAL FEEDING SYSTEM
K043044
Viasys Medsystems
Gastroenterology & Urology · 183d
Cleared Jan 28, 2005
INFANT FEEDING TUBE
K042112
Marian Medical, Inc.
Gastroenterology & Urology · 176d