OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS— 510(k) K080187

Substantially Equivalent

Olsen Medical

FDA 510(k) clearance K080187 for OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS, Substantially Equivalent on 2008-05-09. Applicant: Olsen Medical.

Clearance details

Applicant: Olsen Medical
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2008-01-25
Decision date: 2008-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, 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.