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FDA 510(k)

Self-Cath and Self-Cath Plus

Número K: K221401 · 2022-12-02

RequerenteColoplast
Data da decisão2022-12-02
Código do produtoEZD
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Self-Cath and Self-Cath Plus is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K221401. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Self-Cath and Self-Cath Plus?

Self-Cath and Self-Cath Plus is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Coloplast. The 510(k) number is K221401.

When did Self-Cath and Self-Cath Plus receive FDA 510(k) clearance?

Self-Cath and Self-Cath Plus received FDA 510(k) clearance on 2022-12-02, under 510(k) number K221401.

Who is the listed applicant for Self-Cath and Self-Cath Plus?

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 Self-Cath and Self-Cath Plus?

The FDA product code for Self-Cath and Self-Cath Plus is EZD.

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Dispositivos Relacionados (Código: EZD)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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