HEMORRHAGE OCCLUDER PIN— 510(k) K040109

Substantially Equivalent

Tools For Surgery, LLC

FDA 510(k) clearance K040109 for HEMORRHAGE OCCLUDER PIN, Substantially Equivalent on 2004-03-25. Applicant: Tools For Surgery, LLC.

Clearance details

Applicant: Tools For Surgery, LLC
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 2004-01-20
Decision date: 2004-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.