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
73–96 of 650
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 Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476
Boston Scientific Corporation
Gastroenterology & Urology · 101d
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 Jun 28, 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551
Olympus Medical Systems Corporation
Gastroenterology & Urology · 15d
Cleared May 11, 2005
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 174d
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 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 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297
Boston Scientific Corp
Gastroenterology & Urology · 190d
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 Dec 15, 1999
TRIP TONOMETRY CATHETER, 14F
K993296
Datex-Ohmeda, Inc.
Gastroenterology & Urology · 75d