ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES— 510(k) K991140

Substantially Equivalent

Oratec Interventions, Inc.

FDA 510(k) clearance K991140 for ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES, Substantially Equivalent on 1999-10-25. Applicant: Oratec Interventions, Inc..

Clearance details

Applicant: Oratec Interventions, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1999-04-05
Decision date: 1999-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, 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.