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FDA 510(k)

Disposable Hemostatic Clips

K-Number: K232969 · 2024-06-07

ApplicantNingbo Xinwell Medical Technology Co., Ltd.
Decision Date2024-06-07
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemostatic Clips is a medical device manufactured by Ningbo Xinwell Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under approval number K232969. 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 Hemostatic Clips?

Disposable Hemostatic Clips is a medical device that received FDA 510(k) clearance on 2024-06-07. It is manufactured by Ningbo Xinwell Medical Technology Co., Ltd.. The 510(k) number is K232969.

When was Disposable Hemostatic Clips approved by the FDA?

Disposable Hemostatic Clips received FDA 510(k) clearance on 2024-06-07, under approval number K232969.

What company makes Disposable Hemostatic Clips?

Disposable Hemostatic Clips is manufactured by Ningbo Xinwell Medical Technology Co., Ltd..

What is the FDA product code for Disposable Hemostatic Clips?

The FDA product code for Disposable Hemostatic Clips is PKL.

Related Clinical Trials

NCT07517783 "Comparison of Clip-Based and Clipless Laparoscopic Gallbladder Surgery in Controlling Bleeding" COMPLETED

Other Devices by Ningbo Xinwell Medical Technology Co., Ltd.

K232200Disposable Injection Needles

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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