GENICON BIPOLAR FORCEPS MODEL # 600-005-005— 510(k) K041968

Substantially Equivalent

Genicon

FDA 510(k) clearance K041968 for GENICON BIPOLAR FORCEPS MODEL # 600-005-005, Substantially Equivalent on 2004-11-03. Applicant: Genicon.

Clearance details

Applicant: Genicon
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2004-07-21
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Maitland, FL, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.