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FDA 510(k)

Fiagon Navigation – PointerTube Straight and PointerTube Keat

N.º K: K163416 · 2017-02-16

SolicitanteFiagon GmbH
Fecha de decisión2017-02-16
Código de productoPGW
Comité asesorNE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Fiagon Navigation – PointerTube Straight and PointerTube Keat is the device name listed in this FDA 510(k) record. The listed applicant is Fiagon GmbH. It received FDA 510(k) clearance on 2017-02-16 under 510(k) number K163416. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Fiagon Navigation – PointerTube Straight and PointerTube Keat?

Fiagon Navigation – PointerTube Straight and PointerTube Keat is a medical device that received FDA 510(k) clearance on 2017-02-16. The listed applicant is Fiagon GmbH. The 510(k) number is K163416.

When did Fiagon Navigation – PointerTube Straight and PointerTube Keat receive FDA 510(k) clearance?

Fiagon Navigation – PointerTube Straight and PointerTube Keat received FDA 510(k) clearance on 2017-02-16, under 510(k) number K163416.

Who is the listed applicant for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

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

What is the FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat?

The FDA product code for Fiagon Navigation – PointerTube Straight and PointerTube Keat is PGW.

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Fuente oficial

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