BERGEN MODEL 500 ELECTROSURGERY GENERATOR— 510(k) K972299

Substantially Equivalent

Bergen Mfg.

FDA 510(k) clearance K972299 for BERGEN MODEL 500 ELECTROSURGERY GENERATOR, Substantially Equivalent on 1997-08-27. Applicant: Bergen Mfg..

Clearance details

Applicant: Bergen Mfg.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1997-06-19
Decision date: 1997-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Port Richey, 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.