FDA 510(k)

HYBRIDknife® flex

N.º K: K232033 · 2023-11-29

Fecha de decisión2023-11-29

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HYBRIDknife® flex is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K232033. 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 HYBRIDknife® flex?

HYBRIDknife® flex is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K232033.

When did HYBRIDknife® flex receive FDA 510(k) clearance?

HYBRIDknife® flex received FDA 510(k) clearance on 2023-11-29, under 510(k) number K232033.

Who is the listed applicant for HYBRIDknife® flex?

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

What is the FDA product code for HYBRIDknife® flex?

The FDA product code for HYBRIDknife® flex is GEI.

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Fuente oficial

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