K100163 is an FDA 510(k) clearance for the NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by Vygon Corp. (Montgomeryville, US). The FDA issued a Cleared decision on October 13, 2011, 631 days after receiving the submission on January 20, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K100163 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 20, 2010 |
| Decision Date | October 13, 2011 |
| Days to Decision | 631 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 |