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
145–168 of 651
Cleared Dec 17, 2004
CORTRAK
K041987
Viasys Medsystems
Gastroenterology & Urology · 147d
Cleared Dec 16, 2004
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258
Teleflex Medical
Gastroenterology & Urology · 22d
Cleared Dec 10, 2004
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114
Kimberly-Clark Corp.
Gastroenterology & Urology · 30d
Cleared Dec 02, 2004
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
K043027
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 05, 2004
KENDALL CO2NFIRM NOW CO2 DETECTOR
K042572
Kendall
Gastroenterology & Urology · 45d
Cleared Oct 25, 2004
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
K042300
Applied Medical Technology, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 01, 2004
NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
K030784
Applied Medical Technology, Inc.
Gastroenterology & Urology · 386d
Cleared Dec 12, 2003
FASTRAC GASTRIC ACCESS PORT KIT
K033562
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 11, 2003
COOK GASTRIC SIZING BALLOON CATHETER
K030841
Cook, Inc.
Gastroenterology & Urology · 116d
Cleared Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
K031538
Boston Scientific Corp
Gastroenterology & Urology · 42d
Cleared Apr 17, 2003
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
K030855
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Sep 05, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Jul 16, 2002
INFANT FEEDING TUBES
K020005
Promedic, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297
Boston Scientific Corp
Gastroenterology & Urology · 190d
Cleared May 06, 2002
PPD BALLOON DILATATION CATHETER
K020379
Telemed Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 26, 2002
RUSCH MILLER-ABBOTT TUBE
K010797
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Feb 26, 2002
RUSCH CANTOR TUBE
K010798
Rusch Intl.
Gastroenterology & Urology · 347d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162
Medcomp
Gastroenterology & Urology · 28d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 26, 2000
GASTRIC LAVAGE VALVE
K990365
T-Med Vac Corporation
Gastroenterology & Urology · 537d
Cleared Mar 15, 2000
SIGHTSURE OPERATION INDICATOR, MODEL SS301
K993358
Medevices, Inc.
Gastroenterology & Urology · 161d
Cleared Feb 10, 2000
NASOGASTRIC TUBE HOLDER, MODEL 160
K994300
Dale Medical Products, Inc.
Gastroenterology & Urology · 51d