FIAB SPA, MODELS F7244, F7233, F7234, F7277— 510(k) K100333

Substantially Equivalent

Fiab Spa

FDA 510(k) clearance K100333 for FIAB SPA, MODELS F7244, F7233, F7234, F7277, Substantially Equivalent on 2010-06-21. Applicant: Fiab Spa.

Clearance details

Applicant: Fiab Spa
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2010-02-05
Decision date: 2010-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vicchio Florence, IT

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.