FDA 510(k)

Válvula de Biópsia Andorate, Irrigador de Biópsia Andorate

Número K: K200481 · 2020-06-18

Data da decisão2020-06-18

Código do produtoODC

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Andorate Biopsy Valve, Andorate Biopsy Irrigator is the device name listed in this FDA 510(k) record. The listed applicant is Ga Health Company Limited. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K200481. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Andorate Biopsy Valve, Andorate Biopsy Irrigator?

Andorate Biopsy Valve, Andorate Biopsy Irrigator is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Ga Health Company Limited. The 510(k) number is K200481.

When did Andorate Biopsy Valve, Andorate Biopsy Irrigator receive FDA 510(k) clearance?

Andorate Biopsy Valve, Andorate Biopsy Irrigator received FDA 510(k) clearance on 2020-06-18, under 510(k) number K200481.

Who is the listed applicant for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

The FDA 510(k) record lists Ga Health Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

The FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator is ODC.

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 Ga Health Company Limited como candidato(a)

K232118ANDORATE® Valve Kit K231602Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing K230932ANDORATE® Valve Kit K230280ANDORATE® Suction Valve and ANDORATE® Biopsy Valve K223171AquaPulse® Irrigation Tubing K213095andorate Suction Valve, andorate Air/Water Valve

Ver todos os 12 dispositivos →

Dispositivos Relacionados (Código: ODC)

K252933DYNE PORTDyne Medical Group, Inc.K250145Biopsy Port AdapterEndosound, Inc.K252910Orca Air/Water and Suction ValvesBoston Scientific K250949Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)Olympus Medical Systems Corporation K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation

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.