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FDA 510(k)

Sutter Arrowtip Monopolar Electrodes

K-Number: K192128 · 2019-10-04

ApplicantSutter Medizintechnik GmbH
Decision Date2019-10-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sutter Arrowtip Monopolar Electrodes is a medical device manufactured by Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2019-10-04 under approval number K192128. 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 Arrowtip Monopolar Electrodes?

Sutter Arrowtip Monopolar Electrodes is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Sutter Medizintechnik GmbH. The 510(k) number is K192128.

When was Sutter Arrowtip Monopolar Electrodes approved by the FDA?

Sutter Arrowtip Monopolar Electrodes received FDA 510(k) clearance on 2019-10-04, under approval number K192128.

What company makes Sutter Arrowtip Monopolar Electrodes?

Sutter Arrowtip Monopolar Electrodes is manufactured by Sutter Medizintechnik GmbH.

What is the FDA product code for Sutter Arrowtip Monopolar Electrodes?

The FDA product code for Sutter Arrowtip Monopolar Electrodes is GEI.

Other Devices by Sutter Medizintechnik GmbH

K171869Sutter CURIS RF Generator 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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