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FDA 510(k)

Single Use Hemoclip

K-Number: K212669 · 2022-05-27

ApplicantZhejiang Chuangxiang Medical Technology Co., Ltd.
Decision Date2022-05-27
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K212669. 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 Single Use Hemoclip?

Single Use Hemoclip is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K212669.

When did Single Use Hemoclip receive FDA 510(k) clearance?

Single Use Hemoclip received FDA 510(k) clearance on 2022-05-27, under 510(k) number K212669.

Who is the listed applicant for Single Use Hemoclip?

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

What is the FDA product code for Single Use Hemoclip?

The FDA product code for Single Use Hemoclip is PKL.

Other records listing Zhejiang Chuangxiang Medical 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.

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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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