ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM— 510(k) K961069

Substantially Equivalent

Arthrocare Corp.

FDA 510(k) clearance K961069 for ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM, Substantially Equivalent on 1996-05-28. Applicant: Arthrocare Corp..

Clearance details

Applicant: Arthrocare Corp.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 1996-03-18
Decision date: 1996-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.