FDA 510(k)

EnCor MRI导引器套装，EnCor探头导引器

K号: K161805 · 2016-07-19

决定日期2016-07-19

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

EnCor MRI Introducer Set, EnCor Probe Introducer is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K161805. 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 EnCor MRI Introducer Set, EnCor Probe Introducer?

EnCor MRI Introducer Set, EnCor Probe Introducer is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Senorx, Inc.. The 510(k) number is K161805.

When did EnCor MRI Introducer Set, EnCor Probe Introducer receive FDA 510(k) clearance?

EnCor MRI Introducer Set, EnCor Probe Introducer received FDA 510(k) clearance on 2016-07-19, under 510(k) number K161805.

Who is the listed applicant for EnCor MRI Introducer Set, EnCor Probe Introducer?

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

What is the FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer?

The FDA product code for EnCor MRI Introducer Set, EnCor Probe Introducer is KNW.

列明Senorx, Inc.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。

K233220EnCor Enspire™乳腺活检系统（E4115，E4230）；EnCor™乳腺活检驱动器（DRENCOR）；EnCor™MRI乳腺活检驱动器（DRENCORMR）；EnCor™乳腺活检驱动器探头（ECP017G，ECP017GV，ECP0110G，ECP0110GV，ECP0112G，ECP0112GV）；EnCor™MRI乳腺活检探头（ECPMR017G，ECPMR0110G，ECPMR0110GBT）K210654EnCor乳腺活检探头带冲洗管

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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