FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)— 510(k) K032667

Substantially Equivalent

Focus Medical, LLC

FDA 510(k) clearance K032667 for FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW), Substantially Equivalent on 2004-01-23. Applicant: Focus Medical, LLC.

Clearance details

Applicant: Focus Medical, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-08-28
Decision date: 2004-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethel, CT, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.