FDA 510(k)

WellCare Anoscope

Número K: K230439 · 2023-12-22

RequerenteWell Care (Wuhan) Medical Technology Co., Ltd.

Data da decisão2023-12-22

Código do produtoFER

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

WellCare Anoscope is the device name listed in this FDA 510(k) record. The listed applicant is Well Care (Wuhan) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K230439. The device is classified under product code FER. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WellCare Anoscope?

WellCare Anoscope is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Well Care (Wuhan) Medical Technology Co., Ltd.. The 510(k) number is K230439.

When did WellCare Anoscope receive FDA 510(k) clearance?

WellCare Anoscope received FDA 510(k) clearance on 2023-12-22, under 510(k) number K230439.

Who is the listed applicant for WellCare Anoscope?

The FDA 510(k) record lists Well Care (Wuhan) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WellCare Anoscope?

The FDA product code for WellCare Anoscope is FER.

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Fonte oficial

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