FDA 510(k)

SpeediCath Standard

Número K: K180258 · 2018-10-25

Data da decisão2018-10-25

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpeediCath Standard is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K180258. 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 Standard?

SpeediCath Standard is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Coloplast. The 510(k) number is K180258.

When did SpeediCath Standard receive FDA 510(k) clearance?

SpeediCath Standard received FDA 510(k) clearance on 2018-10-25, under 510(k) number K180258.

Who is the listed applicant for SpeediCath Standard?

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 Standard?

The FDA product code for SpeediCath Standard 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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