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
169–192 of 651
Cleared Jan 12, 2000
AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
K992719
Amsino Intl., Inc.
Gastroenterology & Urology · 153d
Cleared Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
K993296
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 29, 1999
NUTRISAFE EXTENSION TUBE
K991918
Vygon Corp.
Gastroenterology & Urology · 144d
Cleared Oct 20, 1999
BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KIT
K993138
Ballard Medical Products
Gastroenterology & Urology · 30d
Cleared Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
K991375
C.R. Bard, Inc.
Gastroenterology & Urology · 142d
Cleared Aug 25, 1999
FLEXIFLO ENTERAL FEEDING TUBE
K992494
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Aug 24, 1999
TRIP TONOMETRY CATHETER, 8F
K992181
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 26, 1999
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
K991668
Novartis Nutrition Corp.
Gastroenterology & Urology · 73d
Cleared Apr 06, 1999
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE
K990863
Ross Product Div. Abbott Laboratories
Gastroenterology & Urology · 21d
Cleared Mar 22, 1999
MOSS GASTROSTOMY TUBE
K990389
Moss Tubes, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 17, 1999
MODIFICATION OF MOSS P.E.G. TRAY
K984628
Moss Tubes, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 01, 1999
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476
Navion Biomedical Corp.
Gastroenterology & Urology · 150d
Cleared Feb 24, 1999
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
K984310
Moss Tubes, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 10, 1999
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)
K990127
Corpak Medsystems
Gastroenterology & Urology · 28d
Cleared Jan 27, 1999
CHAIT CECOSTOMY CATHETER
K982500
Cook, Inc.
Gastroenterology & Urology · 191d
Cleared Dec 23, 1998
TRIP TONOMETRY CATHETER, 16F
K983366
Datex-Engstrom, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 09, 1998
COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE
K981323
Novartis Nutrition Corp.
Gastroenterology & Urology · 179d
Cleared Sep 11, 1998
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT
K982894
Ballard Medical Products
Gastroenterology & Urology · 25d
Cleared Aug 17, 1998
A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
K971434
Applied Medical Technologies
Gastroenterology & Urology · 486d
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 Apr 16, 1998
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
K980305
Applied Medical Technology, Inc.
Gastroenterology & Urology · 79d
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