FDA 510(k)

Uramix CuraWay Biopsy Needle

N.º K: K203141 · 2021-09-17

Fecha de decisión2021-09-17

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Uramix CuraWay Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Uramix, Inc.. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K203141. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Uramix CuraWay Biopsy Needle?

Uramix CuraWay Biopsy Needle is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Uramix, Inc.. The 510(k) number is K203141.

When did Uramix CuraWay Biopsy Needle receive FDA 510(k) clearance?

Uramix CuraWay Biopsy Needle received FDA 510(k) clearance on 2021-09-17, under 510(k) number K203141.

Who is the listed applicant for Uramix CuraWay Biopsy Needle?

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

What is the FDA product code for Uramix CuraWay Biopsy Needle?

The FDA product code for Uramix CuraWay Biopsy Needle is KNW.

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Fuente oficial

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