WOUNDSTAT— 510(k) K081183

Substantially Equivalent

Traumacure, Inc.

FDA 510(k) clearance K081183 for WOUNDSTAT, Substantially Equivalent on 2008-06-19. Applicant: Traumacure, Inc..

Clearance details

Applicant: Traumacure, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2008-04-25
Decision date: 2008-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.