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FDA 510(k)

Disposable Hemoclip (AF series)

K-Number: K231633 · 2024-01-11

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2024-01-11
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemoclip (AF series) is a medical device manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under approval number K231633. 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 (AF series)?

Disposable Hemoclip (AF series) is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K231633.

When was Disposable Hemoclip (AF series) approved by the FDA?

Disposable Hemoclip (AF series) received FDA 510(k) clearance on 2024-01-11, under approval number K231633.

What company makes Disposable Hemoclip (AF series)?

Disposable Hemoclip (AF series) is manufactured by Alton (Shanghai) Medical Instruments Co., Ltd..

What is the FDA product code for Disposable Hemoclip (AF series)?

The FDA product code for Disposable Hemoclip (AF series) is PKL.

Other Devices by Alton (Shanghai) Medical Instruments Co., Ltd.

K230925Disposable Injection Needle AF series K241285Disposable Endoscope Valves Set (AF series) K243039Ureteral Stents (AF-D series) K242635Endoscopic Distal Attachment (AF-D series) K241679Disposable Cytology Brush (AF series)

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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