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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 the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-28 under 510(k) 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. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K222146.

When did Disposable Endoscopic Hemoclip receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Endoscopic Hemoclip?

The FDA 510(k) record lists Jiangsu Vedkang Medical Science and Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Endoscopic Hemoclip?

The FDA product code for Disposable Endoscopic Hemoclip is PKL.

Related Clinical Trials

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NCT07727564A Disposable Endoscopic Closing Device Used for the Closure of Gastrointestinal TissueNOT_YET_RECRUITING

Other records listing Jiangsu Vedkang Medical Science and Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232825Disposable SphincterotomeK232752Stone 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)K230598Stone Extraction BasketsK220089Disposable Polyp SnareK213914Injection Needle

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Related Devices (Code: PKL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AGK252271HemoclipHangzhou 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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