FDA 510(k)

Single Use MultiClip Device

K-Number: K180325 · 2018-06-01

Decision Date2018-06-01

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single Use MultiClip Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180325. 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 MultiClip Device?

Single Use MultiClip Device is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K180325.

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

Single Use MultiClip Device received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180325.

Who is the listed applicant for Single Use MultiClip Device?

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

What is the FDA product code for Single Use MultiClip Device?

The FDA product code for Single Use MultiClip Device is PKL.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

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Related Devices (Code: PKL)

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 Endoscopy K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG K252271HemoclipHangzhou 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.