FDA 510(k)

Uro-N Cystoscope

Número K: K182876 · 2019-07-02

Data da decisão2019-07-02

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Uro-N 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 2019-07-02 under 510(k) number K182876. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Uro-N Cystoscope?

Uro-N Cystoscope is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Uroviu Corporation. The 510(k) number is K182876.

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

Uro-N Cystoscope received FDA 510(k) clearance on 2019-07-02, under 510(k) number K182876.

Who is the listed applicant for Uro-N 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-N Cystoscope?

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

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Fonte oficial

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