K230326 is an FDA 510(k) clearance for the ENFit to ENFit Extension Sets, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Vesco Medical (Westerville, US). The FDA issued a Cleared decision on November 2, 2023, 269 days after receiving the submission on February 6, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K230326 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2023 |
| Decision Date | November 02, 2023 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PIF — Gastrointestinal Tubes With Enteral Specific Connectors |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5980 |
| Definition | To Facilitate Enteral Specific Connections. |