KNT
- Product code
- KNT
- Device name
- Tubes, Gastrointestinal (And Accessories)
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 12 (direct download)
- 510(k) clearances (all years, FDA)
- 651 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261890 | 2026-08-14 | Boehringer Laboratories, LLC | 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® | |
| K253514 | 2026-07-10 | C.R. Bard, Inc. | Minnesota Four-Lumen Esophagogastric Tamponade Tube … | |
| K250389 | 2025-04-10 | Changzhou Xin Neng Yuan Medical Staple… | XNY Disposable Gastric Calibration Tube | FDA |
| K243228 | 2025-03-28 | Convatec | Flexi-Seal AIR (with ENFit Connector) | FDA |
| K242336 | 2025-01-17 | Amb Medtec | hygh-tec Drainage II | |
| K242901 | 2025-01-10 | Tools For Surgery, LLC | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube… | |
| K241169 | 2024-11-22 | Gravitas Medical, Inc. | Entarik NI Feeding Tube System | |
| K241185 | 2024-10-25 | Avanos Medical, Inc. | CORGRIP* SR NG/NI Tube Retention System | — |
| K240965 | 2024-06-06 | Avanos Medical, Inc. | CORTRAK* 2 Enteral Access System (20-0950) | — |
| K233591 | 2024-05-31 | Degania Silicone , Ltd. | Stylus | |
| K241039 | 2024-05-16 | Reshape Lifesciences | ReShape Calibration Tubes (B-2032, B-2036, B-2040); … | |
| K234033 | 2024-05-06 | Boehringer Laboratories, LLC | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (53… | |
| K240039 | 2024-04-17 | Hangzhou Primecare Medical Co., Ltd. | Enteral Feeding Sets | |
| K240069 | 2024-02-08 | Endolumik | Endolumik Gastric Calibration Tube M Series (EGCT36M… | |
| K234145 | 2024-01-26 | Boehringer Laboratories | ViSiGi 3D Gastric Sizing Tube | |
| K222846 | 2023-12-18 | Applied Medical Technology, Inc. | AMT G-Tube Balloon Gastrostomy Feeding Device |
Official FDA classification page: KNT
Classification and pathway per current FDA publications. Data from openFDA (CC0).