FDA 510(k)

Sutter RaVoR Bipolar Electrodes

N.º K: K191732 · 2019-08-30

Fecha de decisión2019-08-30

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sutter RaVoR Bipolar Electrodes 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 2019-08-30 under 510(k) number K191732. 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 RaVoR Bipolar Electrodes?

Sutter RaVoR Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K191732.

When did Sutter RaVoR Bipolar Electrodes receive FDA 510(k) clearance?

Sutter RaVoR Bipolar Electrodes received FDA 510(k) clearance on 2019-08-30, under 510(k) number K191732.

Who is the listed applicant for Sutter RaVoR Bipolar Electrodes?

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 RaVoR Bipolar Electrodes?

The FDA product code for Sutter RaVoR Bipolar Electrodes 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 K171869Generador RF CURIS Sutter

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