K242917 is an FDA 510(k) clearance for the Enteral Drainage System, Enteral Medicine straw, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Hmc Premedical S.P.A. (Mirandola, IT). The FDA issued a Cleared decision on June 18, 2025, 267 days after receiving the submission on September 24, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K242917 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 2024 |
| Decision Date | June 18, 2025 |
| Days to Decision | 267 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. |