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FDA 510(k)

索勒爾微波組織消融（MTA）系統及附件

K 號：K223581 · 2023-03-27

申請人AngioDynamics, Inc.
決定日期2023-03-27
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

Solero Microwave Tissue Ablation (MTA) System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223581. 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 Solero Microwave Tissue Ablation (MTA) System and Accessories?

Solero Microwave Tissue Ablation (MTA) System and Accessories is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K223581.

When did Solero Microwave Tissue Ablation (MTA) System and Accessories receive FDA 510(k) clearance?

Solero Microwave Tissue Ablation (MTA) System and Accessories received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223581.

Who is the listed applicant for Solero Microwave Tissue Ablation (MTA) System and Accessories?

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

What is the FDA product code for Solero Microwave Tissue Ablation (MTA) System and Accessories?

The FDA product code for Solero Microwave Tissue Ablation (MTA) System and Accessories 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 AngioDynamics, 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。

K252509AlphaVac 多功能機械吸引系統 F1885K253106AngioVac 管套K242687NanoKnife 產生器 (H78720300301US0)；NanoKnife 獨一電極啟動探針，15 cm (H787204001090)；NanoKnife 獨一電極啟動探針，25 cm (H787204001100)；NanoKnife 獨一電極探針間隔器 (H787204003010)K240397AlphaVac MMA F1885 系統 (H787253020)K231945VenaCure EVLT NeverTouch 手術套件；VenaCure EVLT NeverTouch 直接手術套件K221883索勒爾微波組織消融（MTA）系統及附件

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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。

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 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.

官方來源

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