FDA 510(k)

Epix Electrosurgical Probe with Smoke Evacuation

Numéro K : K171684 · 2017-08-07

DemandeurApplied Medical Resources Corporation

Date de décision2017-08-07

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Epix Electrosurgical Probe with Smoke Evacuation is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K171684. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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 2017-08-07. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K171684.

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 2017-08-07, under 510(k) number K171684.

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

The FDA 510(k) record lists Applied Medical Resources Corporation 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.

Essais cliniques associés

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Source officielle

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