FDA 510(k)

Haemostasis Clips

N.º K: K241005 · 2025-01-02

SolicitanteJiangxi Zhuoruihua Medical Instrument Co., Ltd.

Fecha de decisión2025-01-02

Código de productoPKL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Haemostasis Clips is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K241005. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Haemostasis Clips?

Haemostasis Clips is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. The 510(k) number is K241005.

When did Haemostasis Clips receive FDA 510(k) clearance?

Haemostasis Clips received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241005.

Who is the listed applicant for Haemostasis Clips?

The FDA 510(k) record lists Jiangxi Zhuoruihua Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Haemostasis Clips?

The FDA product code for Haemostasis Clips is PKL.

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Dispositivos relacionados (Código: PKL)

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Fuente oficial

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