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FDA 510(k)

Disposable Hemoclip

K-Number: K230004 · 2023-07-31

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2023-07-31
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemoclip is a medical device manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under approval number K230004. 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 Disposable Hemoclip?

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

When was Disposable Hemoclip approved by the FDA?

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

What company makes Disposable Hemoclip?

Disposable Hemoclip is manufactured by Yangzhou Fartley Medical Instrument Technology Co., Ltd..

What is the FDA product code for Disposable Hemoclip?

The FDA product code for Disposable Hemoclip is PKL.

Other Devices by Yangzhou Fartley Medical Instrument Technology Co., Ltd.

K222980Pentax Medical Valve Set K220785Clean Connecting Tube K220292Disposable Endoscope Injection Needle K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare K220210Disposable Endoscopy Adapter Set K250732Disposable Endoscopy Valve Set

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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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