StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing— 510(k) K172155

Substantially Equivalent

Statguard, LLC

FDA 510(k) clearance K172155 for StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing, Substantially Equivalent on 2018-04-12. Applicant: Statguard, LLC.

Clearance details

Applicant: Statguard, LLC
Product code: Code QSY
Advisory panel: Unknown
Date received: 2017-07-17
Decision date: 2018-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gladstone, OR, 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.