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FDA 510(k)

Emprint SX Ablation Platform and Accessories

N.º K: K171358 · 2017-09-01

SolicitanteCoviden, LLC
Fecha de decisión2017-09-01
Código de productoNEY
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Emprint SX Ablation Platform and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Coviden, LLC. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K171358. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Emprint SX Ablation Platform and Accessories?

Emprint SX Ablation Platform and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Coviden, LLC. The 510(k) number is K171358.

When did Emprint SX Ablation Platform and Accessories receive FDA 510(k) clearance?

Emprint SX Ablation Platform and Accessories received FDA 510(k) clearance on 2017-09-01, under 510(k) number K171358.

Who is the listed applicant for Emprint SX Ablation Platform and Accessories?

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

What is the FDA product code for Emprint SX Ablation Platform and Accessories?

The FDA product code for Emprint SX Ablation Platform and Accessories is NEY.

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Dispositivos relacionados (Código: NEY)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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.

Fuente oficial

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