FDA 510(k)

Arthrex Synergy RF System

N.º K: K161581 · 2016-09-09

Fecha de decisión2016-09-09

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arthrex Synergy RF System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161581. 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 Arthrex Synergy RF System?

Arthrex Synergy RF System is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Arthrex, Inc.. The 510(k) number is K161581.

When did Arthrex Synergy RF System receive FDA 510(k) clearance?

Arthrex Synergy RF System received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161581.

Who is the listed applicant for Arthrex Synergy RF System?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arthrex Synergy RF System?

The FDA product code for Arthrex Synergy RF System is GEI.

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Fuente oficial

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