K231299 is an FDA 510(k) clearance for the Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector. This device is classified as a Enteral Specific Transition Connectors (Class II - Special Controls, product code PIO).
Submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on January 22, 2024, 263 days after receiving the submission on May 4, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980. Facilitates Enteral Specific Connections Between Aami/cn3(ps):2014 Compliant Connectors And Non Iso 80369-1 Compliant Legacy Enteral Connectors..
| 510(k) Number | K231299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2023 |
| Decision Date | January 22, 2024 |
| Days to Decision | 263 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. |