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FDA 510(k)

AveCure BT Microwave Ablation System

Número K: K192406 · 2020-11-25

RequerenteMedwaves, Inc.
Data da decisão2020-11-25
Código do produtoNEY
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

AveCure BT Microwave Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Medwaves, Inc.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) number K192406. 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 AveCure BT Microwave Ablation System?

AveCure BT Microwave Ablation System is a medical device that received FDA 510(k) clearance on 2020-11-25. The listed applicant is Medwaves, Inc.. The 510(k) number is K192406.

When did AveCure BT Microwave Ablation System receive FDA 510(k) clearance?

AveCure BT Microwave Ablation System received FDA 510(k) clearance on 2020-11-25, under 510(k) number K192406.

Who is the listed applicant for AveCure BT Microwave Ablation System?

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

What is the FDA product code for AveCure BT Microwave Ablation System?

The FDA product code for AveCure BT Microwave Ablation System 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.

K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.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.

Fonte oficial

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