ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE— 510(k) K952072

Substantially Equivalent

Zomed Intl.

FDA 510(k) clearance K952072 for ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE, Substantially Equivalent on 1995-10-04. Applicant: Zomed Intl..

Clearance details

Applicant: Zomed Intl.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1995-05-02
Decision date: 1995-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.