ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;— 510(k) K080282

Substantially Equivalent

Arthrocare Corp.

FDA 510(k) clearance K080282 for ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;, Substantially Equivalent on 2008-02-15. Applicant: Arthrocare Corp..

Clearance details

Applicant: Arthrocare Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2008-02-04
Decision date: 2008-02-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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.