K243638 is an FDA 510(k) clearance for the MV Flow Aspiration Pump (MVFLOWPMP01), a Apparatus, Suction, Ward Use, Portable, Ac-powered (Class II — Special Controls, product code JCX), submitted by Microvention (Aliso Veijo, US). The FDA issued a Cleared decision on June 13, 2025, 200 days after receiving the submission on November 25, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K243638 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2024 |
| Decision Date | June 13, 2025 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCX — Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4780 |