ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS— 510(k) K063538

Substantially Equivalent

Arthrocare Corp.

FDA 510(k) clearance K063538 for ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS, Substantially Equivalent on 2006-12-01. Applicant: Arthrocare Corp..

Clearance details

Applicant: Arthrocare Corp.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-11-24
Decision date: 2006-12-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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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.