FDA 510(k)

Epix Electrosurgical Probe with Smoke Evacuation

N.º K: K151480 · 2016-02-19

Fecha de decisión2016-02-19

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Epix Electrosurgical Probe with Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K151480. 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 Epix Electrosurgical Probe with Smoke Evacuation?

Epix Electrosurgical Probe with Smoke Evacuation is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Applied Medical Resources. The 510(k) number is K151480.

When did Epix Electrosurgical Probe with Smoke Evacuation receive FDA 510(k) clearance?

Epix Electrosurgical Probe with Smoke Evacuation received FDA 510(k) clearance on 2016-02-19, under 510(k) number K151480.

Who is the listed applicant for Epix Electrosurgical Probe with Smoke Evacuation?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Epix Electrosurgical Probe with Smoke Evacuation?

The FDA product code for Epix Electrosurgical Probe with Smoke Evacuation is GEI.

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Fuente oficial

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