K243361 is an FDA 510(k) clearance for the Nutrifit, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by Vygon USA (Lansdale Montgomery, US). The FDA issued a Cleared decision on December 19, 2024, 51 days after receiving the submission on October 29, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K243361 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FPD — Tube, Feeding |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |