K250319
- 510(k) number
- K250319
- Device name
- MFUSE (MS001)
- Applicant
- Machina Medical, Inc. GA · US
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2025-12-15
- Date received
- 2025-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250319.pdf
Official FDA record: K250319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.