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FDA 510(k)

Disposable Hemoclip (AF series)

K-Number: K231633 · 2024-01-11

ApplicantAlton (Shanghai) Medical Instruments Co., Ltd.
Decision Date2024-01-11
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemoclip (AF series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K231633. 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 (AF series)?

Disposable Hemoclip (AF series) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K231633.

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

Disposable Hemoclip (AF series) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K231633.

Who is the listed applicant for Disposable Hemoclip (AF series)?

The FDA 510(k) record lists Alton (Shanghai) Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Hemoclip (AF series)?

The FDA product code for Disposable Hemoclip (AF series) is PKL.

Other records listing Alton (Shanghai) Medical Instruments 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.

K243039Ureteral Stents (AF-D series)K242635Endoscopic Distal Attachment (AF-D series)K241679Disposable Cytology Brush (AF series)K241285Disposable Endoscope Valves Set (AF series)K230925Disposable Injection Needle AF series

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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