FDA 510(k)

Uro-V Cystoscope

N.º K: K171500 · 2018-01-30

Fecha de decisión2018-01-30

Código de productoFAJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Uro-V Cystoscope is the device name listed in this FDA 510(k) record. The listed applicant is Uroviu Corporation. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K171500. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Uro-V Cystoscope?

Uro-V Cystoscope is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Uroviu Corporation. The 510(k) number is K171500.

When did Uro-V Cystoscope receive FDA 510(k) clearance?

Uro-V Cystoscope received FDA 510(k) clearance on 2018-01-30, under 510(k) number K171500.

Who is the listed applicant for Uro-V Cystoscope?

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

What is the FDA product code for Uro-V Cystoscope?

The FDA product code for Uro-V Cystoscope is FAJ.

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Dispositivos relacionados (Código: FAJ)

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Fuente oficial

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