KNT — Tubes, Gastrointestinal (And Accessories) Class II
FDA product code KNT covers "Tubes, Gastrointestinal (And Accessories)", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KNT
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253514 | c.r. bard | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake | July 10, 2026 |
| K250389 | changzhou xin neng yuan medical stapler co | XNY Disposable Gastric Calibration Tube | April 10, 2025 |
| K243228 | convatec | Flexi-Seal AIR (with ENFit Connector) | March 28, 2025 |
| K242336 | amb medtec | hygh-tec Drainage II | January 17, 2025 |
| K242901 | tools for surgery | ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN | January 10, 2025 |
| K241169 | gravitas medical | Entarik NI Feeding Tube System | November 22, 2024 |
| K241185 | avanos medical | CORGRIP* SR NG/NI Tube Retention System | October 25, 2024 |
| K240965 | avanos medical | CORTRAK* 2 Enteral Access System (20-0950) | June 6, 2024 |
| K233591 | degania silicone | Stylus | May 31, 2024 |
| K241039 | reshape lifesciences | ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B | May 16, 2024 |
| K234033 | boehringer laboratories | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | May 6, 2024 |
| K240039 | hangzhou primecare medical co | Enteral Feeding Sets | April 17, 2024 |
| K240069 | endolumik | Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibra | February 8, 2024 |
| K234145 | boehringer laboratories | ViSiGi 3D Gastric Sizing Tube | January 26, 2024 |
| K222846 | applied medical technology | AMT G-Tube Balloon Gastrostomy Feeding Device | December 18, 2023 |
| K230206 | gravitas medical | Entarik Feeding Tube System; Entarik Feeding Tube | March 24, 2023 |
| K222880 | endolumik | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | March 3, 2023 |
| K230131 | reshape lifesciences | ReShape Calibration Tubes | February 15, 2023 |
| K221400 | creative balloons | hygh-tec drainage | February 9, 2023 |
| K222085 | standard bariatrics | Standard Tapered Bougie, 38 Fr. | October 31, 2022 |