Bovie Ultimate High Frequency Electrosurgical Generator— 510(k) K142975

Substantially Equivalent

Bovie Medical Corporation

FDA 510(k) clearance K142975 for Bovie Ultimate High Frequency Electrosurgical Generator, Substantially Equivalent on 2014-12-12. Applicant: Bovie Medical Corporation.

Clearance details

Applicant: Bovie Medical Corporation
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2014-10-14
Decision date: 2014-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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.