FDA 510(k)

ArtiSential Trocar

Número K: K212500 · 2021-12-03

Data da decisão2021-12-03

Código do produtoGCJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ArtiSential Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K212500. 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 ArtiSential Trocar?

ArtiSential Trocar is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Livsmed, Inc.. The 510(k) number is K212500.

When did ArtiSential Trocar receive FDA 510(k) clearance?

ArtiSential Trocar received FDA 510(k) clearance on 2021-12-03, under 510(k) number K212500.

Who is the listed applicant for ArtiSential Trocar?

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

What is the FDA product code for ArtiSential Trocar?

The FDA product code for ArtiSential Trocar 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

Outros registros que listam Livsmed, Inc. como candidato(a)

Ver todos os 12 dispositivos →

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.