FDA 510(k)

Disposable Hemoclip

N.º K: K230004 · 2023-07-31

SolicitanteYangzhou Fartley Medical Instrument Technology Co., Ltd.

Fecha de decisión2023-07-31

Código de productoPKL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K230004. 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 Disposable Hemoclip?

Disposable Hemoclip is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K230004.

When did Disposable Hemoclip receive FDA 510(k) clearance?

Disposable Hemoclip received FDA 510(k) clearance on 2023-07-31, under 510(k) number K230004.

Who is the listed applicant for Disposable Hemoclip?

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

What is the FDA product code for Disposable Hemoclip?

The FDA product code for Disposable Hemoclip is PKL.

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Otros registros que enlistan a Yangzhou Fartley Medical Instrument Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: PKL)

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Fuente oficial

Ver en la base de datos de la FDA →

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