FDA 510(k)

UV5000 Handle

N.º K: K250797 · 2025-09-11

Fecha de decisión2025-09-11

Código de productoFAJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

UV5000 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 2025-09-11 under 510(k) number K250797. 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 UV5000 Handle?

UV5000 Handle is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Uroviu Corporation. The 510(k) number is K250797.

When did UV5000 Handle receive FDA 510(k) clearance?

UV5000 Handle received FDA 510(k) clearance on 2025-09-11, under 510(k) number K250797.

Who is the listed applicant for UV5000 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 UV5000 Handle?

The FDA product code for UV5000 Handle is FAJ.

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Fuente oficial

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