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
97–120 of 650
Cleared Oct 29, 1999
NUTRISAFE EXTENSION TUBE
K991918
Vygon Corp.
Gastroenterology & Urology · 144d
Cleared Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
K991375
C.R. Bard, Inc.
Gastroenterology & Urology · 142d
Cleared Aug 24, 1999
TRIP TONOMETRY CATHETER, 8F
K992181
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 57d
Cleared Jan 27, 1999
CHAIT CECOSTOMY CATHETER
K982500
Cook, Inc.
Gastroenterology & Urology · 191d
Cleared Jun 05, 1998
RUSCH BLAKEMORE 3 LUMEN, STERILE
K981203
Rusch Intl.
Gastroenterology & Urology · 64d
Cleared May 18, 1998
RUSCH BLAKEMORE TUBE - 4 LUMEN (MINNESOTA TYPE)
K973892
Rusch Intl.
Gastroenterology & Urology · 216d
Cleared Mar 23, 1998
VYGON NEO-SUMP
K974806
Vygon Corp.
Gastroenterology & Urology · 90d
Cleared Feb 27, 1998
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
K973409
Davis & Geck, Inc.
Gastroenterology & Urology · 171d
Cleared Jan 12, 1998
LAPAROSCOPIC GASTROSTOMY KIT
K973891
Applied Medical Resources
Gastroenterology & Urology · 90d
Cleared Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554
Abbott Laboratories
Gastroenterology & Urology · 494d
Cleared Oct 02, 1996
FLEXIFLO POLYG GASTOSTOMY TUBE
K963113
Abbott Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 04, 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375
Boston Scientific Corp
Gastroenterology & Urology · 76d
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
Cleared May 09, 1996
KANGAROO FEEDING TUBE PLACMENT STYLET
K960632
Sherwood Medical Co.
Gastroenterology & Urology · 85d
Cleared Apr 26, 1996
WILSON-COOK BALLOON INFLATION DEVICE
K960415
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Mar 29, 1996
PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)
K954879
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 168d
Cleared Mar 29, 1996
P.E.G. PATIENT CARE KIT
K960177
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 08, 1996
KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT
K954429
Sherwood Medical Co.
Gastroenterology & Urology · 168d
Cleared Jan 22, 1996
REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY
K954776
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 108d
Cleared Dec 11, 1995
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249
C.R. Bard, Inc.
Gastroenterology & Urology · 353d
Cleared Aug 18, 1995
HOLLISTER NASOGASTRIC TUBE ATTACHMENT DEVICE
K953232
Hollister, Inc.
Gastroenterology & Urology · 39d
Cleared May 15, 1995
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 992d