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FDA 510(k)

Single Use Hemoclips

K-Number: K234124 · 2024-07-12

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2024-07-12
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Hemoclips is the device name listed in this FDA 510(k) record. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K234124. 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 Hemoclips?

Single Use Hemoclips is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K234124.

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

Single Use Hemoclips received FDA 510(k) clearance on 2024-07-12, under 510(k) number K234124.

Who is the listed applicant for Single Use Hemoclips?

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

What is the FDA product code for Single Use Hemoclips?

The FDA product code for Single Use Hemoclips is PKL.

Other records listing Promisemed Hangzhou Meditech Co., Ltd. as applicant

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.

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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