VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW— 510(k) K030096

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K030096 for VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW, Substantially Equivalent on 2003-03-18. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2003-01-10
Decision date: 2003-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.