FDA 510(k)

SpeediCath Flex Set

N.º K: K222059 · 2022-09-21

Fecha de decisión2022-09-21

Código de productoEZD

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

SpeediCath Flex Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K222059. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SpeediCath Flex Set?

SpeediCath Flex Set is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Coloplast. The 510(k) number is K222059.

When did SpeediCath Flex Set receive FDA 510(k) clearance?

SpeediCath Flex Set received FDA 510(k) clearance on 2022-09-21, under 510(k) number K222059.

Who is the listed applicant for SpeediCath Flex Set?

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

What is the FDA product code for SpeediCath Flex Set?

The FDA product code for SpeediCath Flex Set is EZD.

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Otros registros que enlistan a Coloplast como solicitante

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Fuente oficial

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