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FDA 510(k)

ClearEndoclip

K-Number: K183021 · 2019-06-28

ApplicantFinemedix Co., Ltd.
Decision Date2019-06-28
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearEndoclip is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2019-06-28 under 510(k) number K183021. 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 ClearEndoclip?

ClearEndoclip is a medical device that received FDA 510(k) clearance on 2019-06-28. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K183021.

When did ClearEndoclip receive FDA 510(k) clearance?

ClearEndoclip received FDA 510(k) clearance on 2019-06-28, under 510(k) number K183021.

Who is the listed applicant for ClearEndoclip?

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

What is the FDA product code for ClearEndoclip?

The FDA product code for ClearEndoclip is PKL.

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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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