FDA Product Code
FDA Product Code KNT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5980
510(k) Clearances — 652 records · page 1 of 7
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | 2026-09-30 | Traditional | PDF ↗ |
| K261890 | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | 2026-08-14 | Special | PDF ↗ |
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | C.R. Bard, Inc. | 2026-07-10 | Traditional | PDF ↗ |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 | Traditional | PDF ↗ |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 | Traditional | PDF ↗ |
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025-01-17 | Traditional | PDF ↗ |
| K242901 | 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) | Tools For Surgery, LLC | 2025-01-10 | Traditional | PDF ↗ |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 | Traditional | PDF ↗ |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 | Traditional | PDF ↗ |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 | Traditional | PDF ↗ |
| K241039 | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) | Reshape Lifesciences | 2024-05-16 | Special | PDF ↗ |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024-05-06 | Traditional | PDF ↗ |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 | Traditional | PDF ↗ |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | 2024-02-08 | Special | PDF ↗ |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024-01-26 | Special | PDF ↗ |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023-12-18 | Traditional | PDF ↗ |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 | Traditional | PDF ↗ |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023-03-03 | Traditional | PDF ↗ |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | 2023-02-15 | Special | PDF ↗ |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | 2023-02-09 | Traditional | PDF ↗ |
| K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | 2022-10-31 | Traditional | PDF ↗ |
| K212316 | DoubleChek DC-1001 | Nasogastric Feeding Solutions, Ltd. | 2022-09-30 | Traditional | PDF ↗ |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022-07-28 | Special | PDF ↗ |
| K212407 | Gastric Lightguide (GLG) | Naser Dib Gabinet Lekarksi Nasmed | 2022-07-26 | Traditional | PDF ↗ |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022-06-07 | Traditional | PDF ↗ |
| K220218 | Siren SGT | Tools For Surgery, LLC | 2022-05-18 | Traditional | PDF ↗ |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | 2022-04-22 | Traditional | PDF ↗ |
| K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | 2021-11-17 | Special | PDF ↗ |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | 2021-09-23 | Special | PDF ↗ |
| K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021-06-29 | Traditional | PDF ↗ |
| K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021-04-27 | Traditional | PDF ↗ |
| K202748 | Enteral Feeding Catheter | Medcaptain Life Science Co., Ltd. | 2021-04-09 | Traditional | PDF ↗ |
| K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | 2021-03-24 | Traditional | PDF ↗ |
| K200646 | TubeClear System | Actuated Medical, Inc. | 2020-12-04 | Traditional | PDF ↗ |
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Applied Medical Technology, Inc. | 2020-10-29 | Traditional | PDF ↗ |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical, Inc. | 2020-06-17 | Special | PDF ↗ |
| K191885 | Standard Bougie | Standard Bariatrics | 2020-04-08 | Traditional | PDF ↗ |
| K193325 | Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches | Prosys International, Ltd. | 2020-03-13 | Traditional | PDF ↗ |
| K190977 | Navina Smart System, Navina Classic System | Dentsply Sirona | 2019-11-22 | Traditional | PDF ↗ |
| K190084 | McLean-Ring Enteral Feeding Tube Set | Cook Incorporated | 2019-10-11 | Traditional | PDF ↗ |
| K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | 2019-06-14 | Special | PDF ↗ |
| K191340 | CORTRAK* 2 Equilateral Enteral Access System | Avanos Medical, Inc. | 2019-06-04 | Special | PDF ↗ |
| K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019-05-29 | Traditional | PDF ↗ |
| K183577 | Medline Quick-Clear Wand | Medline Industries, Inc. | 2019-05-04 | Traditional | PDF ↗ |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited | 2019-04-30 | Traditional | PDF ↗ |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K182804 | Traditional Length GJ Feeding Device | Applied Medical Technology, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | 2019-02-13 | Traditional | PDF ↗ |
| K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | 2018-11-13 | Traditional | PDF ↗ |
| K180605 | GastroFlush | Bionix Development Corporation | 2018-10-24 | Traditional | PDF ↗ |
| K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | Covidien | 2018-10-23 | Traditional | PDF ↗ |
| K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018-07-11 | Traditional | PDF ↗ |
| K172556 | TubeClear System | Actuated Medical, Inc. | 2018-06-29 | Traditional | PDF ↗ |
| K180026 | Bowel Management Device, Bowel Management Irrigation Set | Applied Medical Technology, Inc. | 2018-06-01 | Traditional | PDF ↗ |
| K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | Halyard Health, Inc. | 2018-01-26 | Special | PDF ↗ |
| K173355 | Gastric Sizing Balloon Catheter | Cook Incorporated | 2017-11-17 | Special | PDF ↗ |
| K162340 | Stomach Tube | Well Lead Medical Co., Ltd. | 2017-10-11 | Traditional | PDF ↗ |
| K170319 | Low Profile Non-Balloon Feeding Device | Applied Medical Technology, Inc. | 2017-10-06 | Traditional | PDF ↗ |
| K170487 | Navina Classic System | Dentsply Sirona | 2017-09-11 | Traditional | PDF ↗ |
| K160567 | Barone Jejunostomy Catheter Set | Cook Incorporated | 2017-05-18 | Traditional | PDF ↗ |
| K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated | 2017-05-18 | Traditional | PDF ↗ |
| K163002 | Kangaroo Feeding Tube with IRIS Technology | Covidien (Dba Medtronic) | 2017-05-16 | Traditional | PDF ↗ |
| K162906 | Flexi-Seal PROTECT Fecal Management System | Convatec | 2017-03-07 | Traditional | PDF ↗ |
| K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017-02-09 | Traditional | PDF ↗ |
| K163092 | TubeClear Control Box and Clearing Stem | Actuated Medical, Inc. | 2016-11-30 | Traditional | PDF ↗ |
| K162110 | CORGRIP NG/NI Tube Retention System | Corpak Medsystems, Inc. A Division of Haylard Health | 2016-09-15 | Traditional | PDF ↗ |
| K160787 | Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet | Syncro Medical Innovations, Inc. | 2016-08-09 | Traditional | PDF ↗ |
| K152246 | Aquarius Stoma Measuring Device | Degania Silicone , Ltd. | 2016-06-21 | Traditional | PDF ↗ |
| K153506 | Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit | Consure Medical Pvt , Ltd. | 2016-05-06 | Traditional | PDF ↗ |
| K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) | Covidien, LLC | 2016-05-04 | Special | PDF ↗ |
| K153461 | 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 | Maquet Critical Care AB | 2015-12-11 | Special | PDF ↗ |
| K140310 | Peristeen Anal Irrigation System | Coloplast A/S | 2015-09-03 | Traditional | PDF ↗ |
| K150350 | Flexi-Seal Signal Fecal Management System | Convatec, Ltd. | 2015-07-21 | Traditional | PDF ↗ |
| K142548 | MIDSLEEVE | Medical Innovation Development | 2015-06-23 | Traditional | PDF ↗ |
| K142327 | smARTrack Feeding Tube System | Art Healthcare , Ltd. | 2015-06-08 | Traditional | PDF ↗ |
| K142971 | AMT Bridle - Nasal Tube Retention System | Applied Medical Technology, Inc. | 2015-05-26 | Traditional | PDF ↗ |
| K143088 | GastriSail Gastric Positioning System | Covidien | 2015-02-25 | Traditional | PDF ↗ |
| K142792 | AbbVie NJ | AbbVie , Inc. | 2015-01-14 | Traditional | PDF ↗ |
| K142816 | AbbVie J | AbbVie , Inc. | 2015-01-14 | Traditional | PDF ↗ |
| K142793 | AbbVie PEG | AbbVie , Inc. | 2015-01-14 | Traditional | PDF ↗ |
| K143378 | AQUARIUS Gastrostomy Replacement Tube | Degania Silicone , Ltd. | 2014-12-29 | Special | PDF ↗ |
| K133334 | VERITRACT ENTERAL FEEDING TUBE SYSTEM | Veritract, Inc. | 2014-08-26 | Traditional | PDF ↗ |
| K141631 | AQUARIUS EXTENSION FEEDING SET | Degania Silicone , Ltd. | 2014-07-28 | Special | PDF ↗ |
| K133077 | GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET | Generica Medical International, Inc. | 2014-07-28 | Traditional | PDF ↗ |
| K133465 | CONSURE STOOL MANAGEMENT SYSTEM | Consure Medical Pvt , Ltd. | 2014-06-26 | Traditional | PDF ↗ |
| K133087 | ABBVIE PEG | AbbVie , Inc. | 2014-06-19 | Traditional | PDF ↗ |
| K133129 | ABBVIE NJ | AbbVie , Inc. | 2014-06-19 | Traditional | PDF ↗ |
| K133096 | ABB VIE J | AbbVie , Inc. | 2014-06-18 | Traditional | PDF ↗ |
| K131183 | MED-RX ORAL/ENTERAL SYRINGE | Benlan, Inc. | 2014-06-03 | Traditional | PDF ↗ |
| K132686 | AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE | Degania Silicone , Ltd. | 2014-05-12 | Traditional | PDF ↗ |
| K133251 | BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM | C.R. Bard, Inc. | 2014-05-09 | Traditional | PDF ↗ |
| K123555 | KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY | Covidien | 2014-04-09 | Traditional | PDF ↗ |
| K133599 | CORGRIP | Corpak Medsystems | 2014-03-26 | Traditional | PDF ↗ |
| K132424 | METRIXCARE | The Metrix Company | 2014-02-12 | Traditional | PDF ↗ |
| K133881 | MACY CATHETER | Hospi Corporation | 2014-01-24 | Traditional | PDF ↗ |
| K130674 | ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE | Xeridiem Medical Devices | 2014-01-13 | Traditional | PDF ↗ |
| K130611 | ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE | Xeridiem Medical Devices | 2013-12-19 | Traditional | PDF ↗ |
| K131052 | TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS) | Actuated Medical, Inc. | 2013-08-16 | Traditional | PDF ↗ |
| K131532 | ELECTROMAGNETIC TRANSMITTING STYLET | Corpak Medsystems | 2013-08-12 | Traditional | PDF ↗ |
Product code KNT · Class II · Gastroenterology, Urology. Data: openFDA.