FDA 510(k)

静脉射频发生器，静脉射频导管

K号: K232505 · 2024-05-30

申请人Zhejiang Curaway Medical Technology Co., Ltd.

决定日期2024-05-30

产品代码GEI

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决定实质等同

器械摘要

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-30 under 510(k) number K232505. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K232505.

When did Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter receive FDA 510(k) clearance?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter received FDA 510(k) clearance on 2024-05-30, under 510(k) number K232505.

Who is the listed applicant for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

FDA 510(k)记录将浙江科瑞威医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

The FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is GEI.

列明Zhejiang Curaway Medical Technology Co., Ltd.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。

K260517自动核心活检仪器 K244018一次性活检针 K242322骨髓活检针 K241793自动组织芯活检仪器/半自动组织芯活检仪器/一次性同轴活检针 K240758射频发生器系统，Cura RF 电极 K222001不可逆电穿孔消融发生器，不可逆电穿孔探头

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相关器械（代码：GEI）

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。

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