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

Name: FDA 510(k) clearance K031926
Creator: U.S. Food and Drug Administration
Published: 2003-07-17

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.. Device class: 2.

Clearance details

Applicant: Rita Medical Systems, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
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

Download summary PDF View on FDA.gov ↗

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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.