Sutter RaVoR Bipolar Electrodes— 510(k) K191732

Substantially Equivalent

Sutter Medizintechnik GmbH

FDA 510(k) clearance K191732 for Sutter RaVoR Bipolar Electrodes, Substantially Equivalent on 2019-08-30. Applicant: Sutter Medizintechnik GmbH.

Clearance details

Applicant: Sutter Medizintechnik GmbH
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2019-06-28
Decision date: 2019-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

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.