510(k) K250319 ยท QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
MFUSE (MS001)
| Applicant | Machina Medical, Inc., Roswell GA, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Feb 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250319
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.