FDA 510(k)

NEUWAVE 麻醉微波消融系統及附件

K 號：K200081 · 2020-11-13

決定日期2020-11-13

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

NEUWAVE Microwave Ablation System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K200081. 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 NEUWAVE Microwave Ablation System and Accessories?

NEUWAVE Microwave Ablation System and Accessories is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K200081.

When did NEUWAVE Microwave Ablation System and Accessories receive FDA 510(k) clearance?

NEUWAVE Microwave Ablation System and Accessories received FDA 510(k) clearance on 2020-11-13, under 510(k) number K200081.

Who is the listed applicant for NEUWAVE Microwave Ablation System and Accessories?

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

What is the FDA product code for NEUWAVE Microwave Ablation System and Accessories?

The FDA product code for NEUWAVE Microwave Ablation System and Accessories is NEY.

其他以 Neuwave 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。

K232227ABLATE-IQ K231738NEUWAVE™ 麯波消融系統及附件 K220472NEUWAVE 麻醉微波消融系統及附件 K192427消融確認 K173756Certus 140 2.45GHz 消融系統 K171022消融確認

查看所有 10 項裝置 →

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.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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。