FDA 510(k)

Reach and CQ'ENCE Circular Staplers

Número K: K192566 · 2019-10-17

Data da decisão2019-10-17

Código do produtoGDW

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reach and CQ'ENCE Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Reach Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K192566. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reach and CQ'ENCE Circular Staplers?

Reach and CQ'ENCE Circular Staplers is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Reach Surgical, Inc.. The 510(k) number is K192566.

When did Reach and CQ'ENCE Circular Staplers receive FDA 510(k) clearance?

Reach and CQ'ENCE Circular Staplers received FDA 510(k) clearance on 2019-10-17, under 510(k) number K192566.

Who is the listed applicant for Reach and CQ'ENCE Circular Staplers?

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

What is the FDA product code for Reach and CQ'ENCE Circular Staplers?

The FDA product code for Reach and CQ'ENCE Circular Staplers is GDW.

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: GDW)

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.