FDA 510(k)

SpeediCath Compact Set

Número K: K192904 · 2020-11-02

Data da decisão2020-11-02

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpeediCath Compact Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2020-11-02 under 510(k) number K192904. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SpeediCath Compact Set?

SpeediCath Compact Set is a medical device that received FDA 510(k) clearance on 2020-11-02. The listed applicant is Coloplast. The 510(k) number is K192904.

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

SpeediCath Compact Set received FDA 510(k) clearance on 2020-11-02, under 510(k) number K192904.

Who is the listed applicant for SpeediCath Compact 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 Compact Set?

The FDA product code for SpeediCath Compact Set is GBM.

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Outros registros que listam Coloplast como candidato(a)

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Dispositivos Relacionados (Código: GBM)

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Fonte oficial

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