K162254 is an FDA 510(k) clearance for the Cedic Enteral ENFit Transition Connectors, a Enteral Specific Transition Connectors (Class II — Special Controls, product code PIO), submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on May 4, 2017, 267 days after receiving the submission on August 10, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K162254 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 10, 2016 |
| Decision Date | May 04, 2017 |
| Days to Decision | 267 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. |