K240713
- 510(k) number
- K240713
- Device name
- TRAUMAGEL®
- Applicant
- Cresilon, Inc. NY · US
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2024-08-14
- Date received
- 2024-03-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K240713.pdf
Official FDA record: K240713
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.