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
49–72 of 650
Cleared Oct 24, 2018
GastroFlush
K180605
Bionix Development Corporation
Gastroenterology & Urology · 231d
Cleared Oct 23, 2018
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
K180622
Covidien
Gastroenterology & Urology · 228d
Cleared Jul 11, 2018
Aspire Introducer Needle
K180725
Aspire Bariatrics, Inc.
Gastroenterology & Urology · 113d
Cleared Jun 29, 2018
TubeClear System
K172556
Actuated Medical, Inc.
Gastroenterology & Urology · 309d
Cleared Jun 01, 2018
Bowel Management Device, Bowel Management Irrigation Set
K180026
Applied Medical Technology, Inc.
Gastroenterology & Urology · 149d
Cleared Jan 26, 2018
Mic-Key* SF Over-the-Wire Stoma Measuring Device
K173955
Halyard Health, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 17, 2017
Gastric Sizing Balloon Catheter
K173355
Cook Incorporated
Gastroenterology & Urology · 23d
Cleared Sep 11, 2017
Navina Classic System
K170487
Dentsply Sirona
Gastroenterology & Urology · 206d
Cleared May 18, 2017
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
K160509
Cook Incorporated
Gastroenterology & Urology · 449d
Cleared May 18, 2017
Barone Jejunostomy Catheter Set
K160567
Cook Incorporated
Gastroenterology & Urology · 444d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654
Covidien, LLC
Gastroenterology & Urology · 57d
Cleared Sep 03, 2015
Peristeen Anal Irrigation System
K140310
Coloplast A/S
Gastroenterology & Urology · 573d
Cleared Feb 25, 2015
GastriSail Gastric Positioning System
K143088
Covidien
Gastroenterology & Urology · 120d
Cleared May 09, 2014
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251
C.R. Bard, Inc.
Gastroenterology & Urology · 199d
Cleared Apr 09, 2014
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
K123555
Covidien
Gastroenterology & Urology · 506d
Cleared Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804
Hollister, Inc.
Gastroenterology & Urology · 128d
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 Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719
Abbott Laboratories
Gastroenterology & Urology · 123d
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
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 22, 2010
PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE
K103109
C.R. Bard, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 22, 2010
INSTAFLO BOWEL CATHETER SYSTEM KIT
K100273
Hollister, Inc.
Gastroenterology & Urology · 83d
Cleared Nov 23, 2009
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
K083770
Coloplast A/S
Gastroenterology & Urology · 340d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759
Olympus Medical Systems Corporation
Gastroenterology & Urology · 94d