K253609
- 510(k) number
- K253609
- Device name
- TRAUMAGEL® 2.0 Hemostatic Gel
- Applicant
- Cresilon, Inc. NY · US
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2025-12-12
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K253609.pdf
Official FDA record: K253609
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.