FDA 510(k)

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)

Número K: K253481 · 2026-09-14

Data da decisão2026-09-14

Código do produtoPKL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) 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 2026-09-14 under 510(k) number K253481. 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 colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Ovesco Endoscopy AG. The 510(k) number is K253481.

When did colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) receive FDA 510(k) clearance?

colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K253481.

Who is the listed applicant for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

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 colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)?

The FDA product code for colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) is PKL.

Ensaios clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)K242586ArgoCap (200.52)K241858Conjunto BARS (100.60)K221385LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02)K200684gastroduodenal FTRD Set K183309stentfix OTSC System Set

Ver todos os 9 dispositivos →

Dispositivos Relacionados (Código: PKL)

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 K252271HemoclipHangzhou AGS MedTech Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.