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FDA 510(k)

Hemostatic Clip

K-Number: K261741 · 2026-10-02

ApplicantAnrei Medical (Hz) Co., Ltd.
Decision Date2026-10-02
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Hemostatic Clip is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hz) Co., Ltd.. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K261741. 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 Hemostatic Clip?

Hemostatic Clip is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Anrei Medical (Hz) Co., Ltd.. The 510(k) number is K261741.

When did Hemostatic Clip receive FDA 510(k) clearance?

Hemostatic Clip received FDA 510(k) clearance on 2026-10-02, under 510(k) number K261741.

Who is the listed applicant for Hemostatic Clip?

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

What is the FDA product code for Hemostatic Clip?

The FDA product code for Hemostatic Clip is PKL.

Related Clinical Trials

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.

K260487stentFIX System Set (100.50n)Ovesco Endoscopy AGK253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AGK254069Hemoclip (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 Endoscopy

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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