FDA 510(k)

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

K 號：K241793 · 2025-01-24

申請人Zhejiang Curaway Medical Technology Co., Ltd.

決定日期2025-01-24

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle 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 2025-01-24 under 510(k) number K241793. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Zhejiang Curaway Medical Technology Co., Ltd.. The 510(k) number is K241793.

When did Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle receive FDA 510(k) clearance?

Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241793.

Who is the listed applicant for Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

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 Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle?

The FDA product code for Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle is KNW.

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 K240758無線頻率發生器系統，Cura RF 電極 K232505內腔式雷射發生器，內腔式雷射電極导管 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：KNW）

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Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ 乳癌切片及組織移除系統Bard Peripheral Vascular, Inc.K262792Brevera 結石系統搭配 CorLumina 圖像技術（BREVDISP09）Hologic, Inc.K260572骨髓馬克士曼Medimetrix, LLC K261196Promisemed VeriEcto 自動切片針Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR雙真空輔助乳房組織切片系統控制模組；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性探針，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性定位組，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統腳踏開關；Mammotome Prima™ MR雙真空輔助乳房組織切片系統可重用托盤；Mammotome Prima™ MR雙真空輔助乳房組織切片系統電池充電器Devicor Medical Products, Inc.

官方來源

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