SURGICAL BUR— 510(k) K943758

Substantially Equivalent

Komet Medical

FDA 510(k) clearance K943758 for SURGICAL BUR, Substantially Equivalent on 1994-08-22. Applicant: Komet Medical.

Clearance details

Applicant: Komet Medical
Product code: Code GFF
Advisory panel: General, Plastic Surgery
Date received: 1994-08-02
Decision date: 1994-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Savannah, GA, US

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Adverse events under product code GFF

product code GFF

Malfunction: 459
Other: 1
Total: 460

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.