FDA 510(k)

Generador RF CURIS Sutter

N.º K: K171869 · 2018-02-23

Fecha de decisión2018-02-23

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sutter CURIS RF Generator 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 2018-02-23 under 510(k) number K171869. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K171869.

When did Sutter CURIS RF Generator receive FDA 510(k) clearance?

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

Who is the listed applicant for Sutter CURIS RF Generator?

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 Sutter CURIS RF Generator?

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

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Otros registros que enlistan a Sutter Medizintechnik GmbH como solicitante

K251813CURIS II RF Generator (REF 360100-05)K233425FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035)K193587Sutter Swyng non-stick bipolar forceps, single-use K192128Sutter Arrowtip Monopolar Electrodes K191732Sutter RaVoR Bipolar Electrodes

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Fuente oficial

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