FDA 510(k)

Microwave Ablation Antennas

K号: K241825 · 2024-09-20

决定日期2024-09-20

产品代码NEY

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决定实质等同

器械摘要

Microwave Ablation Antennas is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K241825. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Microwave Ablation Antennas?

Microwave Ablation Antennas is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K241825.

When did Microwave Ablation Antennas receive FDA 510(k) clearance?

Microwave Ablation Antennas received FDA 510(k) clearance on 2024-09-20, under 510(k) number K241825.

Who is the listed applicant for Microwave Ablation Antennas?

FDA 510(k)记录中列出Canyon Medical, Inc.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 Microwave Ablation Antennas?

The FDA product code for Microwave Ablation Antennas is NEY.

列明Canyon Medical, Inc.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。

K254179引流导管 K250209聚乙烯醇栓塞微球 K241827微波消融发生器（KY-2000A, KY-2100A）K233031M·Biopsy /SureCore 自动一次性活检针，M·Biopsy /SureCore 半自动一次性活检针，M·Biopsy /SureAim 同轴活检针 K222865M活检/SureCore 自动一次性活检针，M活检/SureCore 半自动一次性活检针，M活检/SureAim 同轴活检针

相关器械（代码：NEY）

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。

K252632微波消融设备Nanjing Dewen Medical Technology Co., Ltd.K253771一次性微波消融天线（DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13）Nanjing Devin Medical Technology Co., Ltd.K250718swiftPro系统（SWF-SPS）；Swift系统（SWF-SYS）Emblation Limited K241827微波消融发生器（KY-2000A, KY-2100A）Canyon Medical, Inc.K240480IntelliBlate 微波消融系统控制台 (IB-CON)；IntelliBlate 微波消融系统移动车 (IB-CART)；IntelliBlate Ximitry 探头组件，13G x 15cm (IB-XPA-1315)；IntelliBlate Ximitry 探头组件，13G x 20cm (IB-XPA-1320)；IntelliBlate Ximitry 探头组件，13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.K240784温度传感器探头 (ABL-18TP20)Varian Medical Systems, Inc.

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