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
Sep 30, 2026K262038danumed StomaMeter
Danumed Medizintechnik GmbH, DE
KNT
Aug 14, 2026K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®
Boehringer Laboratories, LLC
KNT
Jul 10, 2026K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 Fr
C.R. Bard, Inc.
KNT
Apr 10, 2025K250389XNY Disposable Gastric Calibration Tube
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, CN
KNT
Mar 28, 2025K243228Flexi-Seal AIR (with ENFit Connector)
Convatec, GB
KNT
Jan 17, 2025K242336hygh-tec Drainage II
Amb Medtec, DE
KNT
Jan 10, 2025K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36
Tools For Surgery, LLC
KNT
Nov 22, 2024K241169Entarik NI Feeding Tube System
Gravitas Medical, Inc.
KNT
Oct 25, 2024K241185CORGRIP* SR NG/NI Tube Retention System
Avanos Medical, Inc.
KNT
Jun 6, 2024K240965CORTRAK* 2 Enteral Access System (20-0950)
Avanos Medical, Inc.
KNT
May 31, 2024K233591Stylus
Degania Silicone , Ltd., IL
KNT
May 16, 2024K241039ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter
Reshape Lifesciences
KNT
May 6, 2024K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)
Boehringer Laboratories, LLC
KNT
Apr 17, 2024K240039Enteral Feeding Sets
Hangzhou Primecare Medical Co., Ltd., CN
KNT
Feb 8, 2024K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)
Endolumik
KNT
Jan 26, 2024K234145ViSiGi 3D Gastric Sizing Tube
Boehringer Laboratories
KNT
Dec 18, 2023K222846AMT G-Tube Balloon Gastrostomy Feeding Device
Applied Medical Technology, Inc.
KNT
Mar 24, 2023K230206Entarik Feeding Tube System; Entarik Feeding Tube
Gravitas Medical, Inc.
KNT
Mar 3, 2023K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
Endolumik, Inc.
KNT
Feb 15, 2023K230131ReShape Calibration Tubes
Reshape Lifesciences
KNT
Feb 9, 2023K221400hygh-tec drainage
Creative Balloons GmbH, DE
KNT
Oct 31, 2022K222085Standard Tapered Bougie, 38 Fr.
Standard Bariatrics, Inc.
KNT
Sep 30, 2022K212316DoubleChek DC-1001
Nasogastric Feeding Solutions, Ltd., GB
KNT
Jul 28, 2022K221898Gastrointestinal Boundary Identifier (GIBI HD)
Reshape Lifesciences
KNT
Jul 26, 2022K212407Gastric Lightguide (GLG)
Naser Dib Gabinet Lekarksi Nasmed, PL
KNT
Jun 7, 2022K220455Lap-Band System Calibration Tube
Reshape Lifesciences
KNT
May 18, 2022K220218Siren SGT
Tools For Surgery, LLC
KNT
Apr 22, 2022K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)
Avanos Medical, Inc.
KNT
Nov 17, 2021K212444Qora Stool Management Kit
Cm Technologies, Inc.
KNT
Sep 23, 2021K212728Standard Bougie, 38 Fr. and Hand Pump
Standard Bariatrics
KNT
Jun 29, 2021K210437Standard Bougie, 38 Fr.
Standard Bariatrics
KNT
Apr 27, 2021K211072Safety Trocar Cannula
Boston Scientific Corporation
KNT
Apr 9, 2021K202748Enteral Feeding Catheter
Medcaptain Life Science Co., Ltd., CN
KNT
Mar 24, 2021K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube
Envizion Medical , Ltd., IL
KNT
Dec 4, 2020K200646TubeClear System
Actuated Medical, Inc.
KNT
Oct 29, 2020K202539Nutriglide(TM) Nasal Feeding Tube
Applied Medical Technology, Inc.
KNT
Jun 17, 2020K201322Entuit Nasal Jejunal Feeding Tube
Wilson-Cook Medical, Inc.
KNT
Apr 8, 2020K191885Standard Bougie
Standard Bariatrics
KNT
Mar 13, 2020K193325Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches
Prosys International, Ltd., GB
KNT
Nov 22, 2019K190977Navina Smart System, Navina Classic System
Dentsply Sirona
KNT
Oct 11, 2019K190084McLean-Ring Enteral Feeding Tube Set
Cook Incorporated
KNT
Jun 14, 2019K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
Envizion Medical , Ltd., IL
KNT
Jun 4, 2019K191340CORTRAK* 2 Equilateral Enteral Access System
Avanos Medical, Inc.
KNT
May 29, 2019K183336Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc.
KNT
May 4, 2019K183577Medline Quick-Clear Wand
Medline Industries, Inc.
KNT
Apr 30, 2019K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
Convatec Limited, GB
KNT
Mar 29, 2019K183508Micro Transgastric-Jejunal Feeding Device
Applied Medical Technology, Inc.
KNT
Mar 1, 2019K182804Traditional Length GJ Feeding Device
Applied Medical Technology, Inc.
KNT
Feb 13, 2019K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
Envizion Medical , Ltd., IL
KNT
Nov 13, 2018K182248Aspire Venting Tube
Aspire Bariatrics, Inc.
KNT

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