TRAUMAGEL® 2.0 Hemostatic Gel— 510(k) K253609

Substantially Equivalent

Cresilon, Inc.

FDA 510(k) clearance K253609 for TRAUMAGEL® 2.0 Hemostatic Gel, Substantially Equivalent on 2025-12-12. Applicant: Cresilon, Inc..

Clearance details

Applicant: Cresilon, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2025-11-18
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Brooklyn, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.