FDA 510(k)

微波消融發生器（KY-2000A、KY-2100A）

K 號：K241827 · 2024-09-26

決定日期2024-09-26

產品代碼NEY

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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)?

FDA 510(k) 記錄將 Canyon Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

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.

其他以 Canyon Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254179引流針管 K250209聚乙烯醇栓塞微球 K241825微波消融天線 K233031M·組織切片 /SureCore 自动一次性組織切片針，M·組織切片 /SureCore 半自動一次性組織切片針，M·組織切片 /SureAim 同軸組織切片針 K222865M 精準切片 /SureCore 一次性自動切片針，M 精準切片 /SureCore 半自動一次性切片針，M 精準切片 /SureAim 同軸切片針

相關器械（代碼：NEY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K252632微波消融設備Nanjing Dewen Medical Technology Co., Ltd.K253771可棄式微波消融天線 (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系統 (SWF-SPS)；Swift系統 (SWF-SYS)Emblation Limited K241825微波消融天線Canyon Medical, Inc.K240480IntelliBlate 麻醉微波消融系統控制台（IB-CON）；IntelliBlate 麻醉微波消融系統移動車（IB-CART）；IntelliBlate Ximitry 探頭組裝，13G x 15cm（IB-XPA-1315）；IntelliBlate Ximitry 探頭組裝，13G x 20cm（IB-XPA-1320）；IntelliBlate Ximitry 探頭組裝，13G x 27cm（IB-XPA-1327）Varian Medical Systems, Inc.K240784溫度感測探針 (ABL-18TP20)Varian Medical Systems, Inc.

官方來源

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