KOMET SURGICAL BUR— 510(k) K883255

Name: FDA 510(k) clearance K883255
Creator: U.S. Food and Drug Administration
Published: 1988-09-15

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.. Device class: 1.

Clearance details

Applicant: Komet Medical, Div. of Brasseler USA I, L.P.
Product code: Code GFF
Device class: Class 1
Regulation: 21 CFR 878.4820
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 ↗

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K950449 — SURGICAL BUR1995-03-01
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K934583 — BURRS1994-01-26
K894438 — MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS1989-08-21

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.