FDA 510(k)

Haemostasis Clips

Numéro K : K241005 · 2025-01-02

DemandeurJiangxi Zhuoruihua Medical Instrument Co., Ltd.

Date de décision2025-01-02

Code produitPKL

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Haemostasis Clips is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K241005. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Haemostasis Clips?

Haemostasis Clips is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. The 510(k) number is K241005.

When did Haemostasis Clips receive FDA 510(k) clearance?

Haemostasis Clips received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241005.

Who is the listed applicant for Haemostasis Clips?

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

What is the FDA product code for Haemostasis Clips?

The FDA product code for Haemostasis Clips is PKL.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : PKL)

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AG 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 Endoscopy K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

Source officielle

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