FDA 510(k)

一次性微波消融针（T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018）

K号: K232241 · 2023-11-13

决定日期2023-11-13

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

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is the device name listed in this FDA 510(k) record. The listed applicant is Betters(Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K232241. 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 Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Betters(Suzhou) Medical Co., Ltd.. The 510(k) number is K232241.

When did Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) receive FDA 510(k) clearance?

Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) received FDA 510(k) clearance on 2023-11-13, under 510(k) number K232241.

Who is the listed applicant for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

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

What is the FDA product code for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)?

The FDA product code for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) is NEY.

列明Betters(Suzhou) Medical 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。

K232240微波消融系统（BD-GT）

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.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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