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FDA 510(k)

Disposable Endoscopic Hemoclip

K-Number: K222146 · 2023-03-28

ApplicantJiangsu Vedkang Medical Science and Technology Co., Ltd.
Decision Date2023-03-28
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Endoscopic Hemoclip is a medical device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under approval number K222146. 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 Endoscopic Hemoclip?

Disposable Endoscopic Hemoclip is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K222146.

When was Disposable Endoscopic Hemoclip approved by the FDA?

Disposable Endoscopic Hemoclip received FDA 510(k) clearance on 2023-03-28, under approval number K222146.

What company makes Disposable Endoscopic Hemoclip?

Disposable Endoscopic Hemoclip is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd..

What is the FDA product code for Disposable Endoscopic Hemoclip?

The FDA product code for Disposable Endoscopic Hemoclip is PKL.

Other Devices by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K220089Disposable Polyp Snare K213914Injection Needle K230598Stone Extraction Baskets K232825Disposable Sphincterotome K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)

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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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