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FDA 510(k)

Disposable Hemoclip

K-Number: K230004 · 2023-07-31

ApplicantYangzhou Fartley Medical Instrument Technology Co., Ltd.
Decision Date2023-07-31
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under 510(k) number K230004. 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 Hemoclip?

Disposable Hemoclip is a medical device that received FDA 510(k) clearance on 2023-07-31. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K230004.

When did Disposable Hemoclip receive FDA 510(k) clearance?

Disposable Hemoclip received FDA 510(k) clearance on 2023-07-31, under 510(k) number K230004.

Who is the listed applicant for Disposable Hemoclip?

The FDA 510(k) record lists Yangzhou Fartley Medical Instrument Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Hemoclip?

The FDA product code for Disposable Hemoclip is PKL.

Other records listing Yangzhou Fartley Medical Instrument Technology 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.

K260423Disposable Endoscopic Distal AttachmentsK250732Disposable Endoscopy Valve SetK222980Pentax Medical Valve SetK220785Clean Connecting TubeK220292Disposable Endoscope Injection NeedleK220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

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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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