FDA 510(k)

Sutter CURIS RF Generator

K-Number: K171869 · 2018-02-23

Decision Date2018-02-23

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Sutter CURIS RF Generator is a medical device manufactured by Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2018-02-23 under approval number K171869. 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 CURIS RF Generator?

Sutter CURIS RF Generator is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by Sutter Medizintechnik GmbH. The 510(k) number is K171869.

When was Sutter CURIS RF Generator approved by the FDA?

Sutter CURIS RF Generator received FDA 510(k) clearance on 2018-02-23, under approval number K171869.

What company makes Sutter CURIS RF Generator?

Sutter CURIS RF Generator is manufactured by Sutter Medizintechnik GmbH.

What is the FDA product code for Sutter CURIS RF Generator?

The FDA product code for Sutter CURIS RF Generator is GEI.

Other Devices by Sutter Medizintechnik GmbH

K192128Sutter Arrowtip Monopolar Electrodes K191732Sutter RaVoR Bipolar 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)

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Official Source

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