AUTOCLIX— 510(k) K810075

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K810075 for AUTOCLIX, Substantially Equivalent on 1981-02-04. Applicant: Biodynamics Corp..

Clearance details

Applicant: Biodynamics Corp.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1981-01-13
Decision date: 1981-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.