FDA 510(k)

UV5000W Handle

Número K: K253226 · 2025-10-23

Data da decisão2025-10-23

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

UV5000W Handle is the device name listed in this FDA 510(k) record. The listed applicant is Uroviu Corporation. It received FDA 510(k) clearance on 2025-10-23 under 510(k) number K253226. 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 UV5000W Handle?

UV5000W Handle is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Uroviu Corporation. The 510(k) number is K253226.

When did UV5000W Handle receive FDA 510(k) clearance?

UV5000W Handle received FDA 510(k) clearance on 2025-10-23, under 510(k) number K253226.

Who is the listed applicant for UV5000W Handle?

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 UV5000W Handle?

The FDA product code for UV5000W Handle is FAJ.

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