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FDA 510(k)

Microwave Ablation Device

Número K: K252632 · 2026-03-02

RequerenteNanjing Dewen Medical Technology Co., Ltd.
Data da decisão2026-03-02
Código do produtoNEY
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: NEY)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253771Disposable Microwave Ablation Antenna (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 System (SWF-SPS); Swift System (SWF-SYS)Emblation LimitedK241827Microwave Ablation Generator (KY-2000A, KY-2100A)Canyon Medical, Inc.K241825Microwave Ablation AntennasCanyon Medical, Inc.K240480IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)Varian Medical Systems, Inc.K240784Temperature Sensor Probe (ABL-18TP20)Varian Medical Systems, Inc.

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