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FDA 510(k)

Disposable Hemostatic Closure Clip Device

K-Number: K220157 · 2022-06-13

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2022-06-13
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemostatic Closure Clip 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 2022-06-13 under 510(k) number K220157. 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 Hemostatic Closure Clip Device?

Disposable Hemostatic Closure Clip Device is a medical device that received FDA 510(k) clearance on 2022-06-13. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K220157.

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

Disposable Hemostatic Closure Clip Device received FDA 510(k) clearance on 2022-06-13, under 510(k) number K220157.

Who is the listed applicant for Disposable Hemostatic Closure Clip 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 Disposable Hemostatic Closure Clip Device?

The FDA product code for Disposable Hemostatic Closure Clip Device 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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