ClearanceBrief
Panels › Gastroenterology, Urology › Product code KNT · Class 2

Tubes, Gastrointestinal (And Accessories)

Regulation 876.5980

3510(k)s in 12 months (652 all time)
26recalls in 12 months (268 all time)
191recalls that name a 510(k)
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Top companies in KNT

Company510(k)sRecalls
Ross Products Division Abbott Laboratories084
C.R. Bard, Inc.1552
Biosearch Medical Products, Inc.350
Avanos Medical, Inc.430
Applied Medical Technology, Inc.1613
Boston Scientific Corp1019
C.R. Bard Access Systems, Inc029
Abbott Laboratories230
Medical Innovations Corp.180
Wilson-Cook Medical, Inc.122
Decided510(k)Device and applicantCode
Oct 24, 2018K180605GastroFlush
Bionix Development Corporation
KNT
Oct 23, 2018K180622Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
Covidien
KNT
Jul 11, 2018K180725Aspire Introducer Needle
Aspire Bariatrics, Inc.
KNT
Jun 29, 2018K172556TubeClear System
Actuated Medical, Inc.
KNT
Jun 1, 2018K180026Bowel Management Device, Bowel Management Irrigation Set
Applied Medical Technology, Inc.
KNT
Jan 26, 2018K173955Mic-Key* SF Over-the-Wire Stoma Measuring Device
Halyard Health, Inc.
KNT
Nov 17, 2017K173355Gastric Sizing Balloon Catheter
Cook Incorporated
KNT
Oct 11, 2017K162340Stomach Tube
Well Lead Medical Co., Ltd., CN
KNT
Oct 6, 2017K170319Low Profile Non-Balloon Feeding Device
Applied Medical Technology, Inc.
KNT
Sep 11, 2017K170487Navina Classic System
Dentsply Sirona
KNT
May 18, 2017K160567Barone Jejunostomy Catheter Set
Cook Incorporated
KNT
May 18, 2017K160509Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
Cook Incorporated
KNT
May 16, 2017K163002Kangaroo Feeding Tube with IRIS Technology
Covidien (Dba Medtronic)
KNT
Mar 7, 2017K162906Flexi-Seal PROTECT Fecal Management System
Convatec, GB
KNT
Feb 9, 2017K161413Low Profile Balloon Feeding Device
Applied Medical Technology, Inc.
KNT
Nov 30, 2016K163092TubeClear Control Box and Clearing Stem
Actuated Medical, Inc.
KNT
Sep 15, 2016K162110CORGRIP NG/NI Tube Retention System
Corpak Medsystems, Inc. A Division of Haylard Health
KNT
Aug 9, 2016K160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preass
Syncro Medical Innovations, Inc.
KNT
Jun 21, 2016K152246Aquarius Stoma Measuring Device
Degania Silicone , Ltd., IL
KNT
May 6, 2016K153506Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
Consure Medical Pvt , Ltd., IN
KNT
May 4, 2016K160654GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
Covidien, LLC
KNT
Dec 11, 2015K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
Maquet Critical Care AB, SE
KNT
Sep 3, 2015K140310Peristeen Anal Irrigation System
Coloplast A/S
KNT
Jul 21, 2015K150350Flexi-Seal Signal Fecal Management System
Convatec, Ltd., GB
KNT
Jun 23, 2015K142548MIDSLEEVE
Medical Innovation Development, FR
KNT
Jun 8, 2015K142327smARTrack Feeding Tube System
Art Healthcare , Ltd., IL
KNT
May 26, 2015K142971AMT Bridle - Nasal Tube Retention System
Applied Medical Technology, Inc.
KNT
Feb 25, 2015K143088GastriSail Gastric Positioning System
Covidien
KNT
Jan 14, 2015K142816AbbVie J
AbbVie , Inc.
KNT
Jan 14, 2015K142793AbbVie PEG
AbbVie , Inc.
KNT
Jan 14, 2015K142792AbbVie NJ
AbbVie , Inc.
KNT
Dec 29, 2014K143378AQUARIUS Gastrostomy Replacement Tube
Degania Silicone , Ltd., IL
KNT
Aug 26, 2014K133334VERITRACT ENTERAL FEEDING TUBE SYSTEM
Veritract, Inc.
KNT
Jul 28, 2014K141631AQUARIUS EXTENSION FEEDING SET
Degania Silicone , Ltd., IL
KNT
Jul 28, 2014K133077GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
Generica Medical International, Inc.
KNT
Jun 26, 2014K133465CONSURE STOOL MANAGEMENT SYSTEM
Consure Medical Pvt , Ltd.
KNT
Jun 19, 2014K133129ABBVIE NJ
AbbVie , Inc.
KNT
Jun 19, 2014K133087ABBVIE PEG
AbbVie , Inc.
KNT
Jun 18, 2014K133096ABB VIE J
AbbVie , Inc.
KNT
Jun 3, 2014K131183MED-RX ORAL/ENTERAL SYRINGE
Benlan, Inc., CA
KNT
May 12, 2014K132686AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
Degania Silicone , Ltd., IL
KNT
May 9, 2014K133251BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
C.R. Bard, Inc.
KNT
Apr 9, 2014K123555KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
Covidien
KNT
Mar 26, 2014K133599CORGRIP
Corpak Medsystems
KNT
Feb 12, 2014K132424METRIXCARE
The Metrix Company
KNT
Jan 24, 2014K133881MACY CATHETER
Hospi Corporation
KNT
Jan 13, 2014K130674ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
Xeridiem Medical Devices
KNT
Dec 19, 2013K130611ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
Xeridiem Medical Devices
KNT
Aug 16, 2013K131052TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS)
Actuated Medical, Inc.
KNT
Aug 12, 2013K131532ELECTROMAGNETIC TRANSMITTING STYLET
Corpak Medsystems
KNT

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