FDA 510(k)

Biliary Pancreaticobiliary Scope System

Número K: K241444 · 2025-01-21

RequerenteShenzhen HugeMed Medical Technical Development Co., Ltd.

Data da decisão2025-01-21

Código do produtoFBN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Biliary Pancreaticobiliary Scope 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 2025-01-21 under 510(k) number K241444. 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 Biliary Pancreaticobiliary Scope System?

Biliary Pancreaticobiliary Scope System is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K241444.

When did Biliary Pancreaticobiliary Scope System receive FDA 510(k) clearance?

Biliary Pancreaticobiliary Scope System received FDA 510(k) clearance on 2025-01-21, under 510(k) number K241444.

Who is the listed applicant for Biliary Pancreaticobiliary Scope 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 Biliary Pancreaticobiliary Scope System?

The FDA product code for Biliary Pancreaticobiliary Scope System is FBN.

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Dispositivos Relacionados (Código: FBN)

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Fonte oficial

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