FDA 510(k)

Choledochoscope System

Número K: K231497 · 2024-03-06

RequerenteShenzhen HugeMed Medical Technical Development Co., Ltd.

Data da decisão2024-03-06

Código do produtoFBN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Choledochoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K231497. The device is classified under product code FBN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Choledochoscope System?

Choledochoscope System is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K231497.

When did Choledochoscope System receive FDA 510(k) clearance?

Choledochoscope System received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231497.

Who is the listed applicant for Choledochoscope System?

The FDA 510(k) record lists Shenzhen HugeMed Medical Technical Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Choledochoscope System?

The FDA product code for Choledochoscope System is FBN.

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Dispositivos Relacionados (Código: FBN)

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Fonte oficial

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