FDA 510(k)

RocaJJ软支架

K号: K173734 · 2018-03-12

决定日期2018-03-12

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

RocaJJ Soft Stents is the device name listed in this FDA 510(k) record. The listed applicant is Promepla Sam. It received FDA 510(k) clearance on 2018-03-12 under 510(k) number K173734. 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 RocaJJ Soft Stents?

RocaJJ Soft Stents is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Promepla Sam. The 510(k) number is K173734.

When did RocaJJ Soft Stents receive FDA 510(k) clearance?

RocaJJ Soft Stents received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173734.

Who is the listed applicant for RocaJJ Soft Stents?

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

What is the FDA product code for RocaJJ Soft Stents?

The FDA product code for RocaJJ Soft Stents is FAD.

列明Promepla Sam为申报人的其他记录

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。

K182144Bi-Flex Evo K152278ENDOFLOW II - 灌洗、加温和吸引系统

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 Corporation K232920RELIEF™ 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。