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FDA 510(k)

SurBlate Ablation System

Número K: K223272 · 2023-02-28

RequerenteMima-Pro Scientific, Inc.
Data da decisão2023-02-28
Código do produtoNEY
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

SurBlate Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Mima-Pro Scientific, Inc.. It received FDA 510(k) clearance on 2023-02-28 under 510(k) number K223272. 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 SurBlate Ablation System?

SurBlate Ablation System is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Mima-Pro Scientific, Inc.. The 510(k) number is K223272.

When did SurBlate Ablation System receive FDA 510(k) clearance?

SurBlate Ablation System received FDA 510(k) clearance on 2023-02-28, under 510(k) number K223272.

Who is the listed applicant for SurBlate Ablation System?

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

What is the FDA product code for SurBlate Ablation System?

The FDA product code for SurBlate 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.

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