FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MFUSE (MS001)
K Number: K250319
·
Decision Dec 15, 2025
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
1
Review Days
314
Basic Information
- Device Name
- MFUSE (MS001)
- K Number
- K250319
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Machina Medical, Inc.
- Date Received
- February 4, 2025
- Decision Date
- December 15, 2025
- Product Code
- QSY
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QSY), ordered by most recent decision date.
BloodSTOP iX Trauma Matrix (TM-iX-20)
FDA 510(k)
FDA Unclassified
·Unknown
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm
FDA 510(k)
FDA Unclassified
·Unknown
TRAUMAGEL® 2.0 Hemostatic Gel
FDA 510(k)
FDA Unclassified
·Unknown
TRAUMAGEL®
FDA 510(k)
FDA Unclassified
·Unknown
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
FDA 510(k)
FDA Unclassified
·Unknown
Hemoblock_S (Prescription); Hemoblock_S (OTC)
FDA 510(k)
FDA Unclassified
·Unknown