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
97–120 of 651
Cleared Dec 19, 2013
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611
Xeridiem Medical Devices
Gastroenterology & Urology · 287d
Cleared Aug 16, 2013
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
K131052
Actuated Medical, Inc.
Gastroenterology & Urology · 123d
Cleared Aug 12, 2013
ELECTROMAGNETIC TRANSMITTING STYLET
K131532
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Jun 26, 2013
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653
Kimberly Clark Corporation
Gastroenterology & Urology · 299d
Cleared Apr 19, 2013
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
K123716
Applied Medical Technology, Inc.
Gastroenterology & Urology · 136d
Cleared Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804
Hollister, Inc.
Gastroenterology & Urology · 128d
Cleared Mar 28, 2013
BOEHRINGER GASTRIC SIZING TUBE
K130483
Boehringer Laboratories, LLC
Gastroenterology & Urology · 31d
Cleared Dec 20, 2012
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
K123659
Actuated Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 05, 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030
Degania Silicone , Ltd.
Gastroenterology & Urology · 56d
Cleared Jun 13, 2012
TUBECLEAR
K121571
Actuated Medical, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 08, 2012
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER
K112860
Coloplast A/S
Gastroenterology & Urology · 252d
Cleared May 11, 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511
Covidien Lp, Formerly Registered AS Kendall
Gastroenterology & Urology · 255d
Cleared Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342
Convatec, Inc.
Gastroenterology & Urology · 255d
Cleared Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719
Abbott Laboratories
Gastroenterology & Urology · 123d
Cleared Apr 19, 2012
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
K120182
Neomed, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 29, 2012
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN
K112863
Acta Medical, LLC
Gastroenterology & Urology · 181d
Cleared Mar 19, 2012
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
K112268
Codan US Corp.
Gastroenterology & Urology · 224d
Cleared Feb 17, 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272
Kentec Medical, Inc.
Gastroenterology & Urology · 18d
Cleared Jan 10, 2012
CORTRAK ENTERAL ACCESS DEVICE
K113351
Corpak Medsystems
Gastroenterology & Urology · 57d
Cleared Oct 19, 2011
AMT G-J TUBE
K110804
Applied Medical Technology, Inc.
Gastroenterology & Urology · 211d
Cleared Sep 29, 2011
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
K112434
Bd Medical Surgical
Gastroenterology & Urology · 36d
Cleared Aug 04, 2011
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
K110005
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 213d
Cleared Jul 22, 2011
ENDOFLIP GASTRIC TUBE
K110529
Crospon, Ltd.
Gastroenterology & Urology · 148d
Cleared Jan 31, 2011
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
K103254
Coloplast A/S
Gastroenterology & Urology · 89d