Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sutter RaVoR Bipolar Electrodes

K-Number: K191732 · 2019-08-30

ApplicantSutter Medizintechnik GmbH
Decision Date2019-08-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sutter RaVoR Bipolar Electrodes is a medical device manufactured by Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2019-08-30 under approval number K191732. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sutter RaVoR Bipolar Electrodes?

Sutter RaVoR Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2019-08-30. It is manufactured by Sutter Medizintechnik GmbH. The 510(k) number is K191732.

When was Sutter RaVoR Bipolar Electrodes approved by the FDA?

Sutter RaVoR Bipolar Electrodes received FDA 510(k) clearance on 2019-08-30, under approval number K191732.

What company makes Sutter RaVoR Bipolar Electrodes?

Sutter RaVoR Bipolar Electrodes is manufactured by Sutter Medizintechnik GmbH.

What is the FDA product code for Sutter RaVoR Bipolar Electrodes?

The FDA product code for Sutter RaVoR Bipolar Electrodes is GEI.

Related Clinical Trials

NCT07192172 Enhanced Radiofrequency Ablation for Recurrent HCC Post-TACE Using Twin Internally Cooled-Perfusion Electrodes COMPLETED

Other Devices by Sutter Medizintechnik GmbH

K171869Sutter CURIS RF Generator K192128Sutter Arrowtip Monopolar Electrodes K193587Sutter Swyng non-stick bipolar forceps, single-use K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) K251813CURIS II RF Generator (REF 360100-05)

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑