K151628 is an FDA 510(k) clearance for the Medline ENFit Connectors. This device is classified as a Enteral Specific Transition Connectors (Class II - Special Controls, product code PIO).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on July 24, 2015, 37 days after receiving the submission on June 17, 2015.
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 | K151628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2015 |
| Decision Date | July 24, 2015 |
| Days to Decision | 37 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. |