Aviso: Este site agrega dados públicos oficiais da FDA, ClinicalTrials.gov, PubMed e SEC EDGAR apenas para referência geral. Não constitui aconselhamento médico, diagnóstico, recomendação de tratamento ou aconselhamento de investimento.

FDA 510(k)

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

Número K: K212868 · 2022-01-26

RequerenteRocamed Sam
Data da decisão2022-01-26
Código do produtoFAD
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is the device name listed in this FDA 510(k) record. The listed applicant is Rocamed Sam. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212868. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Rocamed Sam. The 510(k) number is K212868.

When did JFil Ureteral Stents, JFil Ureteral Stents ECO KIT receive FDA 510(k) clearance?

JFil Ureteral Stents, JFil Ureteral Stents ECO KIT received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212868.

Who is the listed applicant for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

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

What is the FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT?

The FDA product code for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT is FAD.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: FAD)

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.

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific CorporationK232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

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.

↑