360 HEMOCLIP APPLIERS— 510(k) K791157

Substantially Equivalent

Edward Weck, Inc.

FDA 510(k) clearance K791157 for 360 HEMOCLIP APPLIERS, Substantially Equivalent on 1979-06-27. Applicant: Edward Weck, Inc..

Clearance details

Applicant: Edward Weck, Inc.
Product code: Code GDO
Advisory panel: General, Plastic Surgery
Date received: 1979-06-21
Decision date: 1979-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GDO

product code GDO

Death: 5
Malfunction: 2,124
Total: 2,129

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.