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FDA 510(k)

SureClip(TM) Repositionable Hemostasis Clip

K-Number: K161463 · 2017-01-06

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2017-01-06
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SureClip(TM) Repositionable Hemostasis Clip 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 2017-01-06 under 510(k) number K161463. 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 SureClip(TM) Repositionable Hemostasis Clip?

SureClip(TM) Repositionable Hemostasis Clip is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K161463.

When did SureClip(TM) Repositionable Hemostasis Clip receive FDA 510(k) clearance?

SureClip(TM) Repositionable Hemostasis Clip received FDA 510(k) clearance on 2017-01-06, under 510(k) number K161463.

Who is the listed applicant for SureClip(TM) Repositionable Hemostasis Clip?

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 SureClip(TM) Repositionable Hemostasis Clip?

The FDA product code for SureClip(TM) Repositionable Hemostasis Clip is PKL.

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

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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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