FDA 510(k)

Microwave Ablation Generator (KY-2000A, KY-2100A)

Número K: K241827 · 2024-09-26

Data da decisão2024-09-26

Código do produtoNEY

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microwave Ablation Generator (KY-2000A, KY-2100A) is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2024-09-26 under 510(k) number K241827. 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 Generator (KY-2000A, KY-2100A)?

Microwave Ablation Generator (KY-2000A, KY-2100A) is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K241827.

When did Microwave Ablation Generator (KY-2000A, KY-2100A) receive FDA 510(k) clearance?

Microwave Ablation Generator (KY-2000A, KY-2100A) received FDA 510(k) clearance on 2024-09-26, under 510(k) number K241827.

Who is the listed applicant for Microwave Ablation Generator (KY-2000A, KY-2100A)?

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

What is the FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A)?

The FDA product code for Microwave Ablation Generator (KY-2000A, KY-2100A) is NEY.

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Outros registros que listam Canyon Medical, Inc. como candidato(a)

K254179Drainage Catheter K250209Polyvinyl Alcohol Embolic Microspheres K241825Microwave Ablation Antennas K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle

Dispositivos Relacionados (Código: NEY)

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 Limited 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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