K151237 is an FDA 510(k) clearance for the Nutrisafe 2- ENFit Adaptor, a Enteral Specific Transition Connectors (Class II — Special Controls, product code PIO), submitted by Vygon (Lansdale Montgomery, US). The FDA issued a Cleared decision on February 9, 2016, 274 days after receiving the submission on May 11, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K151237 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 11, 2015 |
| Decision Date | February 09, 2016 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PIO — Enteral Specific Transition Connectors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors. |