Product code KNT
- Device name
- Tubes, Gastrointestinal (And Accessories)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | 2026-08-14 |
| 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 |
| K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
| K243228 | Flexi-Seal AIR (with ENFit Connector) | Convatec | 2025-03-28 |
| K242336 | hygh-tec Drainage II | Amb Medtec | 2025-01-17 |
| 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 Orog... | Tools For Surgery, LLC | 2025-01-10 |
| K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024-11-22 |
| K241185 | CORGRIP* SR NG/NI Tube Retention System | Avanos Medical, Inc. | 2024-10-25 |
| K240965 | CORTRAK* 2 Enteral Access System (20-0950) | Avanos Medical, Inc. | 2024-06-06 |
| K233591 | Stylus | Degania Silicone , Ltd. | 2024-05-31 |
| 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 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024-05-06 |
| K240039 | Enteral Feeding Sets | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
| K240069 | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) | Endolumik | 2024-02-08 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024-01-26 |
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023-12-18 |
| K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023-03-24 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023-03-03 |
| K230131 | ReShape Calibration Tubes | Reshape Lifesciences | 2023-02-15 |
| K221400 | hygh-tec drainage | Creative Balloons GmbH | 2023-02-09 |
| K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | 2022-10-31 |
| K212316 | DoubleChek DC-1001 | Nasogastric Feeding Solutions, Ltd. | 2022-09-30 |
| K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022-07-28 |
| K212407 | Gastric Lightguide (GLG) | Naser Dib Gabinet Lekarksi Nasmed | 2022-07-26 |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022-06-07 |
| K220218 | Siren SGT | Tools For Surgery, LLC | 2022-05-18 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | 2022-04-22 |
| K212444 | Qora Stool Management Kit | Cm Technologies, Inc. | 2021-11-17 |
| K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | 2021-09-23 |
| K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021-06-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G461CEGCT40M0 | Endolumik | Endolumik, Inc. | 2026-08-25 |
| 00350770009117 | CORTRAK* Enteral Access System - Reusable Cable | Avanos Medical, Inc. | 2026-08-21 |
| 00350770009094 | CORTRAK* Enteral Access System | Avanos Medical, Inc. | 2026-08-21 |
| 00350770007922 | CORTRAK* Enteral Access System - Reusable Cable | Avanos Medical, Inc. | 2026-08-21 |
| 00350770006840 | CORTRAK* Enteral Access System | Avanos Medical, Inc. | 2026-08-21 |
| 00860007229428 | Qora | CM TECHNOLOGIES, INC. | 2025-03-12 |
| 05060182171894 | AVANTGARDE | PROSYS INTERNATIONAL LIMITED | 2023-10-20 |
| 00768455209620 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2023-08-16 |
| 04260566430123 | hygh-tec | Advanced Medical Balloons GmbH | 2023-03-06 |
| 04260566430116 | hygh-tec | Advanced Medical Balloons GmbH | 2023-03-06 |
| 00768455145836 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2019-11-18 |
| 00768455157150 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2019-11-18 |
| 00860974000334 | Qora Collection Bag | Consure Medical Private Limited | 2017-11-30 |
| 00860974000341 | Qora Aeon Stool Management Kit | Consure Medical Private Limited | 2017-11-23 |
| 00860974000358 | Qora AIM Stool Management Kit | Consure Medical Private Limited | 2017-11-23 |
| 00768455143016 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2017-05-12 |
| 30768455143017 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2017-04-26 |
| 20884521706177 | Kangaroo | Cardinal Health, Inc. | 2017-04-20 |
| 00801741113147 | Bard® DigniShield® Stool Management System with ENFit™ | C. R. Bard, Inc. | 2016-11-03 |
| 00610075179626 | ActiFlo | HOLLISTER INCORPORATED | 2016-09-21 |
| 00610075179657 | ActiFlo | HOLLISTER INCORPORATED | 2016-09-21 |
| 00610075179640 | ActiFlo | HOLLISTER INCORPORATED | 2016-09-21 |
| 00610075179633 | ActiFlo | HOLLISTER INCORPORATED | 2016-09-21 |
| 00610075040070 | InstaFlo | HOLLISTER INCORPORATED | 2016-09-21 |
| 00768455109852 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 00768455108565 | FLEXI-SEAL | CONVATEC, PURCHASING DEPARTMENT | 2016-09-01 |
| 00801741045943 | Bard® DigniShield® Stool Management System | C. R. Bard, Inc. | 2016-08-25 |
| 00860974000327 | Qora Arida Stool Management Kit | Consure Medical Private Limited | 2016-08-10 |
| 00860974000310 | Qora Aeon Stool Management Kit | Consure Medical Private Limited | 2016-08-10 |
| 00860974000303 | Qora AIM Stool Management Kit | Consure Medical Private Limited | 2016-08-10 |