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FDA 510(k)

Disposable Hemostatic Clips

K-Number: K232969 · 2024-06-07

ApplicantNingbo Xinwell Medical Technology Co., Ltd.
Decision Date2024-06-07
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hemostatic Clips is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K232969. 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 Clips?

Disposable Hemostatic Clips is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Ningbo Xinwell Medical Technology Co., Ltd.. The 510(k) number is K232969.

When did Disposable Hemostatic Clips receive FDA 510(k) clearance?

Disposable Hemostatic Clips received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232969.

Who is the listed applicant for Disposable Hemostatic Clips?

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

What is the FDA product code for Disposable Hemostatic Clips?

The FDA product code for Disposable Hemostatic Clips is PKL.

Other records listing Ningbo Xinwell Medical 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.

K232200Disposable Injection Needles

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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