BURS FOR MICRO SURGICAL DRILL SYSTEM— 510(k) K853658

Substantially Equivalent

Acumed Instruments Corp.

FDA 510(k) clearance K853658 for BURS FOR MICRO SURGICAL DRILL SYSTEM, Substantially Equivalent on 1985-09-24. Applicant: Acumed Instruments Corp..

Clearance details

Applicant: Acumed Instruments Corp.
Product code: Code GFF
Advisory panel: General, Plastic Surgery
Date received: 1985-09-03
Decision date: 1985-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.