KOMET SURGICAL BUR— 510(k) K883255

Substantially Equivalent

Komet Medical, Div. of Brasseler USA I, L.P.

FDA 510(k) clearance K883255 for KOMET SURGICAL BUR, Substantially Equivalent on 1988-09-15. Applicant: Komet Medical, Div. of Brasseler USA I, L.P..

Clearance details

Applicant: Komet Medical, Div. of Brasseler USA I, L.P.
Product code: Code GFF
Advisory panel: General, Plastic Surgery
Date received: 1988-08-02
Decision date: 1988-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Savannah, GA, US

Download summary PDF View on FDA.gov ↗

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.