FDA 510(k)

BARS Set (100.60)

Numéro K : K241858 · 2024-08-26

Date de décision2024-08-26

Code produitPKL

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

BARS Set (100.60) is the device name listed in this FDA 510(k) record. The listed applicant is Ovesco Endoscopy AG. It received FDA 510(k) clearance on 2024-08-26 under 510(k) number K241858. 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 BARS Set (100.60)?

BARS Set (100.60) is a medical device that received FDA 510(k) clearance on 2024-08-26. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K241858.

When did BARS Set (100.60) receive FDA 510(k) clearance?

BARS Set (100.60) received FDA 510(k) clearance on 2024-08-26, under 510(k) number K241858.

Who is the listed applicant for BARS Set (100.60)?

The FDA 510(k) record lists Ovesco Endoscopy AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARS Set (100.60)?

The FDA product code for BARS Set (100.60) is PKL.

Autres dossiers indiquant Ovesco Endoscopy AG en tant que demandeur

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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