FDA 510(k)

ShenDa Sinuscope

Número K: K161298 · 2017-08-25

RequerenteShenyang Shenda Endoscope Co., Ltd.

Data da decisão2017-08-25

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

ShenDa Sinuscope is the device name listed in this FDA 510(k) record. The listed applicant is Shenyang Shenda Endoscope Co., Ltd.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K161298. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ShenDa Sinuscope?

ShenDa Sinuscope is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Shenyang Shenda Endoscope Co., Ltd.. The 510(k) number is K161298.

When did ShenDa Sinuscope receive FDA 510(k) clearance?

ShenDa Sinuscope received FDA 510(k) clearance on 2017-08-25, under 510(k) number K161298.

Who is the listed applicant for ShenDa Sinuscope?

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

What is the FDA product code for ShenDa Sinuscope?

The FDA product code for ShenDa Sinuscope is EOB.

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: EOB)

K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)Karl Storz SE & CO. KG K261544Hydro Irrigation SystemStryker Instruments K254133ENTity USB Videoscope SystemOptim, LLC K253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems Corporation K241731Outlook Surgical Versa One System (8900139)Resnent, LLC

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.