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FDA 510(k)

Haemostasis Clips

K-Number: K241005 · 2025-01-02

ApplicantJiangxi Zhuoruihua Medical Instrument Co., Ltd.
Decision Date2025-01-02
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Haemostasis Clips?

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

When was Haemostasis Clips approved by the FDA?

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

What company makes Haemostasis Clips?

Haemostasis Clips is manufactured by Jiangxi Zhuoruihua Medical Instrument Co., Ltd..

What is the FDA product code for Haemostasis Clips?

The FDA product code for Haemostasis Clips is PKL.

Related Devices (Code: PKL)

K153550FTRD System SetOvesco Endoscopy AG K170867FTRD System SetOvesco Endoscopy AG K161463SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd. K172727HemoclipHangzhou AGS MedTech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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