K250319 is an FDA 510(k) clearance for the MFUSE (MS001), a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Machina Medical, Inc. (Roswell, US). The FDA issued a Cleared decision on December 15, 2025, 314 days after receiving the submission on February 4, 2025. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K250319 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2025 |
| Decision Date | December 15, 2025 |
| Days to Decision | 314 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device Class | — |
| Definition | To Temporarily Control Bleeding And Cover External Wounds. |