RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)— 510(k) K031926

Substantially Equivalent

Rita Medical Systems, Inc.

FDA 510(k) clearance K031926 for RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER), Substantially Equivalent on 2003-07-17. Applicant: Rita Medical Systems, Inc..

Clearance details

Applicant: Rita Medical Systems, Inc.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2003-06-23
Decision date: 2003-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, 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.