FDA 510(k)

內腔式雷射發生器，內腔式雷射電極导管

K 號：K232505 · 2024-05-30

申請人Zhejiang Curaway Medical Technology Co., Ltd.

決定日期2024-05-30

產品代碼GEI

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

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-30 under 510(k) number K232505. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is a medical device that received FDA 510(k) clearance on 2024-05-30. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K232505.

When did Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter receive FDA 510(k) clearance?

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter received FDA 510(k) clearance on 2024-05-30, under 510(k) number K232505.

Who is the listed applicant for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

FDA 510(k) 記錄將浙江庫瑞威醫療技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter?

The FDA product code for Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter is GEI.

其他以 Zhejiang Curaway Medical Technology Co., Ltd. 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。

K260517自動核心針吸組織切片儀 K244018一次性組織切片針 K242322骨髓穿刺針 K241793自動核心針吸儀器/半自動核心針吸儀器/一次性同軸針吸針 K240758無線頻率發生器系統，Cura RF 電極 K222001不可逆電穿孔消融發生器，不可逆電穿孔探針

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相關器械（代碼：GEI）

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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