FDA 510(k)

Conjunto BARS (100.60)

Número K: K241858 · 2024-08-26

Data da decisão2024-08-26

Código do produtoPKL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Outros registros que listam Ovesco Endoscopy AG como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)K242586ArgoCap (200.52)K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)K200684gastroduodenal FTRD Set K183309stentfix OTSC System Set

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Dispositivos Relacionados (Código: 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

Fonte oficial

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