FDA 510(k)

微波消融天線

K 號：K241825 · 2024-09-20

決定日期2024-09-20

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 Antennas 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 2024-09-20 under 510(k) number K241825. 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 Antennas?

Microwave Ablation Antennas is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K241825.

When did Microwave Ablation Antennas receive FDA 510(k) clearance?

Microwave Ablation Antennas received FDA 510(k) clearance on 2024-09-20, under 510(k) number K241825.

Who is the listed applicant for Microwave Ablation Antennas?

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 Antennas?

The FDA product code for Microwave Ablation Antennas 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 K241827微波消融發生器（KY-2000A、KY-2100A）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 K241827微波消融發生器（KY-2000A、KY-2100A）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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