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FDA 510(k)

JFil 肾盂输尿管支架，JFil 肾盂输尿管支架 ECO KIT

K号: K212868 · 2022-01-26

申请人Rocamed Sam
决定日期2022-01-26
产品代码FAD
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：FAD）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251890一次性输尿管支架Zhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura®输尿管支架和支架套装Cathegenix (Xiamen) Co., Ltd.K243039输尿管支架（AF-D系列）Alton (Shanghai) Medical Instruments Co., Ltd.K243830一次性输尿管支架Shenzhen Trious Medical Technology Co., Ltd.K250824Percuflex输尿管支架；Percuflex Plus输尿管支架；Percuflex Plus SureDrive可弯曲输尿管支架套装；Contour输尿管支架；Contour SureDrive可弯曲输尿管支架套装；Contour VL可变长度输尿管支架；Contour VL SureDrive可弯曲输尿管支架套装；Polaris Ultra输尿管支架；Polaris Loop输尿管支架；Tria Firm输尿管支架；Tria Soft输尿管支架；Percuflex尿液分流支架套装Boston Scientific CorporationK232920RELIEF™ 肾盂支架套件；型号：RS-001 - 6 Fr x 24cm，RELIEF™ 肾盂支架套件；型号：RS-002 - 6 Fr x 26cmUreteral Stent Company

官方来源

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