FDA 510(k)

CURIS II RF Generator (REF 360100-05)

Número K: K251813 · 2026-02-11

Data da decisão2026-02-11

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CURIS II RF Generator (REF 360100-05) is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K251813. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K251813.

When did CURIS II RF Generator (REF 360100-05) receive FDA 510(k) clearance?

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

Who is the listed applicant for CURIS II RF Generator (REF 360100-05)?

The FDA 510(k) record lists Sutter Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

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.

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Fonte oficial

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