K121105 is an FDA 510(k) clearance for the NUTRISAFE 2 FEEDING TUBE. This device is classified as a Tube, Feeding (Class II — Special Controls, product code FPD).
Submitted by Vygon Corp. (Montgomeryville, US). The FDA issued a Cleared decision on December 18, 2012, 250 days after receiving the submission on April 12, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K121105 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 2012 |
| Decision Date | December 18, 2012 |
| Days to Decision | 250 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 |