FDA 510(k)

自动组织芯活检仪器/半自动组织芯活检仪器/一次性同轴活检针

K号: K241793 · 2025-01-24

申请人Zhejiang Curaway Medical Technology Co., Ltd.

决定日期2025-01-24

产品代码KNW

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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)记录将浙江科瑞威医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Zhejiang Curaway Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260517自动核心活检仪器 K244018一次性活检针 K242322骨髓活检针 K240758射频发生器系统，Cura RF 电极 K232505静脉射频发生器，静脉射频导管 K222001不可逆电穿孔消融发生器，不可逆电穿孔探头

查看所有 7 个设备 →

相关器械（代码：KNW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260517自动核心活检仪器Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™乳腺活检和组织移除系统Bard Peripheral Vascular, Inc.K262792Brevera活检系统，配备CorLumina成像技术（BREVDISP09）Hologic, Inc.K260572骨髓马克思曼Medimetrix, LLC K261196Promisemed VeriEcto 自动活检针Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR 双真空辅助乳腺活检系统控制模块；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性探头，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性靶向套件，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统脚踏开关；Mammotome Prima™ MR 双真空辅助乳腺活检系统可重复使用的托盘；Mammotome Prima™ MR 双真空辅助乳腺活检系统电池充电器Devicor Medical Products, Inc.

官方来源

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