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FDA 510(k)

Disposable hemoclip

K-Number: K213217 · 2022-11-14

ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2022-11-14
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-14 under 510(k) number K213217. 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?

Disposable hemoclip is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K213217.

When did Disposable hemoclip receive FDA 510(k) clearance?

Disposable hemoclip received FDA 510(k) clearance on 2022-11-14, under 510(k) number K213217.

Who is the listed applicant for Disposable hemoclip?

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

What is the FDA product code for Disposable hemoclip?

The FDA product code for Disposable hemoclip is PKL.

Other records listing Beijing Zksk 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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