K233034 is an FDA 510(k) clearance for the Mobility+ Enteral Feeding System OTC, a Gastrointestinal Tubes With Enteral Specific Connectors (Class II — Special Controls, product code PIF), submitted by Rockfield Medical (Galway, IE). The FDA issued a Cleared decision on April 12, 2024, 200 days after receiving the submission on September 25, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K233034 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2023 |
| Decision Date | April 12, 2024 |
| Days to Decision | 200 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. |