Atlas FDA

KNT

650 FDA 510(k) clearances · Product code

95 daysmedian time to decision
337 days90th percentile
650clearances measured

FDA profile

Official device name
Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2021: 1,655 · 2022: 1,650 · 2023: 1,863 · 2024: 1,577 · 2025: 1,471 · 2026: 1,275
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514)C.R. Bard, Inc.2026-07-10
XNY Disposable Gastric Calibration Tube (K250389)Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd2025-04-10
Flexi-Seal AIR (with ENFit Connector) (K243228)Convatec2025-03-28
hygh-tec Drainage II (K242336)Amb Medtec2025-01-17
ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (K242901)Tools For Surgery, LLC2025-01-10
Entarik NI Feeding Tube System (K241169)Gravitas Medical, Inc.2024-11-22
CORGRIP* SR NG/NI Tube Retention System (K241185)Avanos Medical, Inc.2024-10-25
CORTRAK* 2 Enteral Access System (20-0950) (K240965)Avanos Medical, Inc.2024-06-06
Stylus (K233591)Degania Silicone , Ltd.2024-05-31
ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039)Reshape Lifesciences2024-05-16
ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033)Boehringer Laboratories, LLC2024-05-06
Enteral Feeding Sets (K240039)Hangzhou Primecare Medical Co., Ltd.2024-04-17
Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) (K240069)Endolumik2024-02-08
ViSiGi 3D Gastric Sizing Tube (K234145)Boehringer Laboratories2024-01-26
AMT G-Tube Balloon Gastrostomy Feeding Device (K222846)Applied Medical Technology, Inc.2023-12-18
Entarik Feeding Tube System; Entarik Feeding Tube (K230206)Gravitas Medical, Inc.2023-03-24
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) (K222880)Endolumik, Inc.2023-03-03
ReShape Calibration Tubes (K230131)Reshape Lifesciences2023-02-15
hygh-tec drainage (K221400)Creative Balloons GmbH2023-02-09
Standard Tapered Bougie, 38 Fr. (K222085)Standard Bariatrics, Inc.2022-10-31
DoubleChek DC-1001 (K212316)Nasogastric Feeding Solutions, Ltd.2022-09-30
Gastrointestinal Boundary Identifier (GIBI HD) (K221898)Reshape Lifesciences2022-07-28
Gastric Lightguide (GLG) (K212407)Naser Dib Gabinet Lekarksi Nasmed2022-07-26
Lap-Band System Calibration Tube (K220455)Reshape Lifesciences2022-06-07
Siren SGT (K220218)Tools For Surgery, LLC2022-05-18
Avanos* CORTRAK* 2 Enteral Access System (EAS) (K220588)Avanos Medical, Inc.2022-04-22
Qora Stool Management Kit (K212444)Cm Technologies, Inc.2021-11-17
Standard Bougie, 38 Fr. and Hand Pump (K212728)Standard Bariatrics2021-09-23
Standard Bougie, 38 Fr. (K210437)Standard Bariatrics2021-06-29
Safety Trocar Cannula (K211072)Boston Scientific Corporation2021-04-27
Enteral Feeding Catheter (K202748)Medcaptain Life Science Co., Ltd.2021-04-09
ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube (K203133)Envizion Medical , Ltd.2021-03-24
TubeClear System (K200646)Actuated Medical, Inc.2020-12-04
Nutriglide(TM) Nasal Feeding Tube (K202539)Applied Medical Technology, Inc.2020-10-29
Entuit Nasal Jejunal Feeding Tube (K201322)Wilson-Cook Medical, Inc.2020-06-17
Standard Bougie (K191885)Standard Bariatrics2020-04-08
Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches (K193325)Prosys International, Ltd.2020-03-13
Navina Smart System, Navina Classic System (K190977)Dentsply Sirona2019-11-22
McLean-Ring Enteral Feeding Tube Set (K190084)Cook Incorporated2019-10-11
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube (K191387)Envizion Medical , Ltd.2019-06-14
CORTRAK* 2 Equilateral Enteral Access System (K191340)Avanos Medical, Inc.2019-06-04
Entuit PEG, Entuit PEGJ (K183336)Wilson-Cook Medical, Inc.2019-05-29
Medline Quick-Clear Wand (K183577)Medline Industries, Inc.2019-05-04
Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) (K190114)Convatec Limited2019-04-30
Micro Transgastric-Jejunal Feeding Device (K183508)Applied Medical Technology, Inc.2019-03-29
Traditional Length GJ Feeding Device (K182804)Applied Medical Technology, Inc.2019-03-01
ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube (K182915)Envizion Medical , Ltd.2019-02-13
Aspire Venting Tube (K182248)Aspire Bariatrics, Inc.2018-11-13
GastroFlush (K180605)Bionix Development Corporation2018-10-24
Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port (K180622)Covidien2018-10-23
Aspire Introducer Needle (K180725)Aspire Bariatrics, Inc.2018-07-11
TubeClear System (K172556)Actuated Medical, Inc.2018-06-29
Bowel Management Device, Bowel Management Irrigation Set (K180026)Applied Medical Technology, Inc.2018-06-01
Mic-Key* SF Over-the-Wire Stoma Measuring Device (K173955)Halyard Health, Inc.2018-01-26
Gastric Sizing Balloon Catheter (K173355)Cook Incorporated2017-11-17
Stomach Tube (K162340)Well Lead Medical Co., Ltd.2017-10-11
Low Profile Non-Balloon Feeding Device (K170319)Applied Medical Technology, Inc.2017-10-06
Navina Classic System (K170487)Dentsply Sirona2017-09-11
Barone Jejunostomy Catheter Set (K160567)Cook Incorporated2017-05-18
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509)Cook Incorporated2017-05-18
Kangaroo Feeding Tube with IRIS Technology (K163002)Covidien (Dba Medtronic)2017-05-16
Flexi-Seal PROTECT Fecal Management System (K162906)Convatec2017-03-07
Low Profile Balloon Feeding Device (K161413)Applied Medical Technology, Inc.2017-02-09
TubeClear Control Box and Clearing Stem (K163092)Actuated Medical, Inc.2016-11-30
CORGRIP NG/NI Tube Retention System (K162110)Corpak Medsystems, Inc. A Division of Haylard Health2016-09-15
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet (K160787)Syncro Medical Innovations, Inc.2016-08-09
Aquarius Stoma Measuring Device (K152246)Degania Silicone , Ltd.2016-06-21
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit (K153506)Consure Medical Pvt , Ltd.2016-05-06
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) (K160654)Covidien, LLC2016-05-04
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 AB2015-12-11
Peristeen Anal Irrigation System (K140310)Coloplast A/S2015-09-03
Flexi-Seal Signal Fecal Management System (K150350)Convatec, Ltd.2015-07-21
MIDSLEEVE (K142548)Medical Innovation Development2015-06-23
smARTrack Feeding Tube System (K142327)Art Healthcare , Ltd.2015-06-08
AMT Bridle - Nasal Tube Retention System (K142971)Applied Medical Technology, Inc.2015-05-26
GastriSail Gastric Positioning System (K143088)Covidien2015-02-25
AbbVie NJ (K142792)AbbVie , Inc.2015-01-14
AbbVie J (K142816)AbbVie , Inc.2015-01-14
AbbVie PEG (K142793)AbbVie , Inc.2015-01-14
AQUARIUS Gastrostomy Replacement Tube (K143378)Degania Silicone , Ltd.2014-12-29
VERITRACT ENTERAL FEEDING TUBE SYSTEM (K133334)Veritract, Inc.2014-08-26
GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET (K133077)Generica Medical International, Inc.2014-07-28
AQUARIUS EXTENSION FEEDING SET (K141631)Degania Silicone , Ltd.2014-07-28
CONSURE STOOL MANAGEMENT SYSTEM (K133465)Consure Medical Pvt , Ltd.2014-06-26
ABBVIE PEG (K133087)AbbVie , Inc.2014-06-19
ABBVIE NJ (K133129)AbbVie , Inc.2014-06-19
ABB VIE J (K133096)AbbVie , Inc.2014-06-18
MED-RX ORAL/ENTERAL SYRINGE (K131183)Benlan, Inc.2014-06-03
AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (K132686)Degania Silicone , Ltd.2014-05-12
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM (K133251)C.R. Bard, Inc.2014-05-09
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY (K123555)Covidien2014-04-09
CORGRIP (K133599)Corpak Medsystems2014-03-26
METRIXCARE (K132424)The Metrix Company2014-02-12
MACY CATHETER (K133881)Hospi Corporation2014-01-24
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130674)Xeridiem Medical Devices2014-01-13
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE (K130611)Xeridiem Medical Devices2013-12-19
TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) (K131052)Actuated Medical, Inc.2013-08-16
ELECTROMAGNETIC TRANSMITTING STYLET (K131532)Corpak Medsystems2013-08-12
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES (K122653)Kimberly-Clark Corporation2013-06-26
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT (K123716)Applied Medical Technology, Inc.2013-04-19
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