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FDA 510(k)

微波消融設備

K 號：K252632 · 2026-03-02

申請人Nanjing Dewen Medical Technology Co., Ltd.
決定日期2026-03-02
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 Device is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252632. 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 Device?

Microwave Ablation Device is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Nanjing Dewen Medical Technology Co., Ltd.. The 510(k) number is K252632.

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

Microwave Ablation Device received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252632.

Who is the listed applicant for Microwave Ablation Device?

The FDA 510(k) record lists Nanjing Dewen Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microwave Ablation Device?

The FDA product code for Microwave Ablation Device is NEY.

相關臨床試驗

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。

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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。

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 LimitedK241827微波消融發生器（KY-2000A、KY-2100A）Canyon Medical, Inc.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.

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