FDA 510(k)

Sutter Swyng non-stick bipolar forceps, single-use

N.º K: K193587 · 2020-02-10

Fecha de decisión2020-02-10

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sutter Swyng non-stick bipolar forceps, single-use 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 2020-02-10 under 510(k) number K193587. 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 Swyng non-stick bipolar forceps, single-use?

Sutter Swyng non-stick bipolar forceps, single-use is a medical device that received FDA 510(k) clearance on 2020-02-10. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K193587.

When did Sutter Swyng non-stick bipolar forceps, single-use receive FDA 510(k) clearance?

Sutter Swyng non-stick bipolar forceps, single-use received FDA 510(k) clearance on 2020-02-10, under 510(k) number K193587.

Who is the listed applicant for Sutter Swyng non-stick bipolar forceps, single-use?

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 Swyng non-stick bipolar forceps, single-use?

The FDA product code for Sutter Swyng non-stick bipolar forceps, single-use 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)K192128Sutter Arrowtip Monopolar Electrodes K191732Sutter RaVoR Bipolar Electrodes K171869Generador RF CURIS Sutter

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