K220165 is an FDA 510(k) clearance for the Enteral Transition Adaptor. This device is classified as a Enteral Specific Transition Connectors (Class II - Special Controls, product code PIO).
Submitted by GBUK Group, Ltd. (Selby, GB). The FDA issued a Cleared decision on October 21, 2022, 274 days after receiving the submission on January 20, 2022.
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 | K220165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |