KNT — Tubes, Gastrointestinal (And Accessories) Class II
FDA Device Classification
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 |
|---|
| 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 |
| K212316 | nasogastric feeding solutions | DoubleChek DC-1001 | September 30, 2022 |