FDA 510(k)

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)

Número K: K240196 · 2024-06-18

Data da decisão2024-06-18

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is the device name listed in this FDA 510(k) record. The listed applicant is Yuwonmeditech Co., Ltd.. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K240196. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Yuwonmeditech Co., Ltd.. The 510(k) number is K240196.

When did Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) receive FDA 510(k) clearance?

Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) received FDA 510(k) clearance on 2024-06-18, under 510(k) number K240196.

Who is the listed applicant for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

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

What is the FDA product code for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)?

The FDA product code for Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) is GCJ.

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

Dispositivos Relacionados (Código: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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.