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
49–72 of 651
Cleared Nov 13, 2018
Aspire Venting Tube
K182248
Aspire Bariatrics, Inc.
Gastroenterology & Urology · 85d
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 Oct 11, 2017
Stomach Tube
K162340
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 415d
Cleared Oct 06, 2017
Low Profile Non-Balloon Feeding Device
K170319
Applied Medical Technology, Inc.
Gastroenterology & Urology · 247d
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 16, 2017
Kangaroo Feeding Tube with IRIS Technology
K163002
Covidien (Dba Medtronic)
Gastroenterology & Urology · 200d
Cleared Mar 07, 2017
Flexi-Seal PROTECT Fecal Management System
K162906
Convatec
Gastroenterology & Urology · 141d
Cleared Feb 09, 2017
Low Profile Balloon Feeding Device
K161413
Applied Medical Technology, Inc.
Gastroenterology & Urology · 262d
Cleared Nov 30, 2016
TubeClear Control Box and Clearing Stem
K163092
Actuated Medical, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 15, 2016
CORGRIP NG/NI Tube Retention System
K162110
Corpak Medsystems, Inc. A Division of Haylard Health
Gastroenterology & Urology · 48d
Cleared Aug 09, 2016
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
K160787
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 140d
Cleared Jun 21, 2016
Aquarius Stoma Measuring Device
K152246
Degania Silicone , Ltd.
Gastroenterology & Urology · 316d
Cleared May 06, 2016
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
K153506
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 151d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654
Covidien, LLC
Gastroenterology & Urology · 57d
Cleared Dec 11, 2015
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
K153461
Maquet Critical Care AB
Gastroenterology & Urology · 10d
Cleared Sep 03, 2015
Peristeen Anal Irrigation System
K140310
Coloplast A/S
Gastroenterology & Urology · 573d