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 C.R. Bard, Inc..

650
Total
650
Cleared
153d
Avg days
1976
Since
650 devices
145–168 of 650
Cleared Apr 14, 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110
Abbott Laboratories
Gastroenterology & Urology · 153d
Cleared Mar 06, 1992
SAECG CARDIOGRAPH MODEL M1754A
K913997
Hewlett-Packard Co.
Gastroenterology & Urology · 182d
Cleared Mar 06, 1992
NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE
K914375
Sherwood Medical Co.
Gastroenterology & Urology · 157d
Cleared Feb 12, 1992
GI BLEEDER/OD SET
K913476
Icu Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Feb 07, 1992
LOPEZ VALVE TM II
K915171
Icu Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jan 15, 1992
DOBBHOFF(R) SINGLE PASS PEG KIT
K913784
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 145d
Cleared Nov 05, 1991
FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP
K913786
Abbott Laboratories
Gastroenterology & Urology · 74d
Cleared Oct 07, 1991
ZIMMON ESOPHAGO-GASTRIC BALLOON TAMPONADE DEVICE
K900623
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 606d
Cleared Sep 05, 1991
WILSON-COOK RUSSELL GASTROSTOMY KIT
K912047
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 07, 1991
FLEXIFLO ENTERAL FEEDING TUBE
K910382
Abbott Laboratories
Gastroenterology & Urology · 190d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897
E-Z-Em, Inc.
Gastroenterology & Urology · 86d
Cleared Mar 19, 1991
FLEXIFLO SACKS-VINE GASTROSTOMY KITS
K910332
Abbott Laboratories
Gastroenterology & Urology · 53d
Cleared Jan 31, 1991
FLEXIFLO STOMATE EXTENSION TUBE
K902623
Abbott Laboratories
Gastroenterology & Urology · 231d
Cleared Dec 12, 1990
PEEWEE REPLACEMENT GASTROSTOMY TUBE
K903662
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 121d
Cleared Nov 27, 1990
FLEXIFLO STOMATE DECOMPRESSION TUBE
K903579
Abbott Laboratories
Gastroenterology & Urology · 111d
Cleared Nov 19, 1990
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325
Abbott Laboratories
Gastroenterology & Urology · 117d
Cleared Nov 07, 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 183d
Cleared Aug 02, 1990
DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE
K900324
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 191d
Cleared Aug 02, 1990
DOBBHOFF(R) ENDOENTERIC GASTRIC DECOMPRESSION CATH
K900563
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 176d
Cleared Aug 02, 1990
BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING
K900590
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 176d
Cleared Aug 02, 1990
DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM
K900624
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 175d
Cleared Jul 02, 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023
Medline Industries, Inc.
Gastroenterology & Urology · 119d
Cleared Jun 29, 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574
Ackrad Laboratories
Gastroenterology & Urology · 87d
Cleared May 02, 1990
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K895366
Fresenius USA, Inc.
Gastroenterology & Urology · 247d