DISPOSABLE INTRA-ARTICULAR BLADE— 510(k) K830434

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K830434 for DISPOSABLE INTRA-ARTICULAR BLADE, Substantially Equivalent on 1983-04-12. Applicant: Concept, Inc..

Clearance details

Applicant: Concept, Inc.
Product code: Code GFA
Advisory panel: General, Plastic Surgery
Date received: 1983-02-09
Decision date: 1983-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GFA

product code GFA

Death: 2
Injury: 140
Malfunction: 2,337
Total: 2,479

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.