CONCEPT C-VAC— 510(k) K842710

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K842710 for CONCEPT C-VAC, Substantially Equivalent on 1984-10-31. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1984-07-12
Decision date: 1984-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.