FDA 510(k)

微波消融发生器（KY-2000A, KY-2100A）

K号: K241827 · 2024-09-26

决定日期2024-09-26

产品代码NEY

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决定实质等同

器械摘要

Microwave Ablation Generator (KY-2000A, KY-2100A) 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 2024-09-26 under 510(k) number K241827. 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 Generator (KY-2000A, KY-2100A)?

Microwave Ablation Generator (KY-2000A, KY-2100A) is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K241827.

When did Microwave Ablation Generator (KY-2000A, KY-2100A) receive FDA 510(k) clearance?

Microwave Ablation Generator (KY-2000A, KY-2100A) received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241827.

Who is the listed applicant for Microwave Ablation Generator (KY-2000A, KY-2100A)?

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 Generator (KY-2000A, KY-2100A)?

The FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A) 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 K241825Microwave Ablation Antennas 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 K241825Microwave Ablation AntennasCanyon 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.

官方来源

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