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FDA 510(k)

NEUWAVE™ 微波消融系统及附件

K号: K231738 · 2023-11-16

申请人Neuwave Medical, Inc.
决定日期2023-11-16
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

NEUWAVE™ Microwave Ablation System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K231738. 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 NEUWAVE™ Microwave Ablation System and Accessories?

NEUWAVE™ Microwave Ablation System and Accessories is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K231738.

When did NEUWAVE™ Microwave Ablation System and Accessories receive FDA 510(k) clearance?

NEUWAVE™ Microwave Ablation System and Accessories received FDA 510(k) clearance on 2023-11-16, under 510(k) number K231738.

Who is the listed applicant for NEUWAVE™ Microwave Ablation System and Accessories?

The FDA 510(k) record lists Neuwave Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUWAVE™ Microwave Ablation System and Accessories?

The FDA product code for NEUWAVE™ Microwave Ablation System and Accessories 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

列明Neuwave 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。

K232227ABLATE-IQK220472NEUWAVE 微波消融系统及附件K200081NEUWAVE 微波消融系统及附件K192427消融确认K173756Certus 140 2.45GHz 消融系统K171022消融确认

查看所有 10 个设备 →

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 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.

官方来源

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