FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TRAUMAGEL® 2.0 Hemostatic Gel
K Number: K253609
·
Decision Dec 12, 2025
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
3
Review Days
24
Basic Information
- Device Name
- TRAUMAGEL® 2.0 Hemostatic Gel
- K Number
- K253609
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cresilon, Inc.
- Date Received
- November 18, 2025
- Decision Date
- December 12, 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 |
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