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FDA 510(k)

微波消融设备

K号: K252632 · 2026-03-02

申请人Nanjing Dewen Medical Technology Co., Ltd.
决定日期2026-03-02
产品代码NEY
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Microwave Ablation Device is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252632. 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 Device?

Microwave Ablation Device is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. The 510(k) number is K252632.

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

Microwave Ablation Device received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252632.

Who is the listed applicant for Microwave Ablation Device?

The FDA 510(k) record lists Nanjing Dewen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microwave Ablation Device?

The FDA product code for Microwave Ablation Device is NEY.

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：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。

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 LimitedK241827微波消融发生器（KY-2000A, KY-2100A）Canyon Medical, Inc.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.

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