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FDA 510(k)

CURIS II RF Generator (REF 360100-05)

K-Number: K251813 · 2026-02-11

ApplicantSutter Medizintechnik GmbH
Decision Date2026-02-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CURIS II RF Generator (REF 360100-05) is a medical device manufactured by Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-02-11 under approval number K251813. 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 CURIS II RF Generator (REF 360100-05)?

CURIS II RF Generator (REF 360100-05) is a medical device that received FDA 510(k) clearance on 2026-02-11. It is manufactured by Sutter Medizintechnik GmbH. The 510(k) number is K251813.

When was CURIS II RF Generator (REF 360100-05) approved by the FDA?

CURIS II RF Generator (REF 360100-05) received FDA 510(k) clearance on 2026-02-11, under approval number K251813.

What company makes CURIS II RF Generator (REF 360100-05)?

CURIS II RF Generator (REF 360100-05) is manufactured by Sutter Medizintechnik GmbH.

What is the FDA product code for CURIS II RF Generator (REF 360100-05)?

The FDA product code for CURIS II RF Generator (REF 360100-05) is GEI.

Other Devices by Sutter Medizintechnik GmbH

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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.

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