FDA 510(k)

PlasmaBlade X 3.0S, PlasmaBlade X 4.0

N.º K: K181257 · 2018-08-02

Fecha de decisión2018-08-02

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2018-08-02 under 510(k) number K181257. 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 PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is a medical device that received FDA 510(k) clearance on 2018-08-02. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K181257.

When did PlasmaBlade X 3.0S, PlasmaBlade X 4.0 receive FDA 510(k) clearance?

PlasmaBlade X 3.0S, PlasmaBlade X 4.0 received FDA 510(k) clearance on 2018-08-02, under 510(k) number K181257.

Who is the listed applicant for PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

The FDA 510(k) record lists Medtronic Advanced Energy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PlasmaBlade X 3.0S, PlasmaBlade X 4.0?

The FDA product code for PlasmaBlade X 3.0S, PlasmaBlade X 4.0 is GEI.

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Fuente oficial

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