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FDA 510(k)

SUREcore Prime 活检仪器

K号: K230646 · 2023-11-29

申请人Uro-1 Medical, Inc.
决定日期2023-11-29
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

SUREcore Prime Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1 Medical, Inc.. It received FDA 510(k) clearance on 2023-11-29 under 510(k) number K230646. 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 SUREcore Prime Biopsy Instrument?

SUREcore Prime Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2023-11-29. The listed applicant is Uro-1 Medical, Inc.. The 510(k) number is K230646.

When did SUREcore Prime Biopsy Instrument receive FDA 510(k) clearance?

SUREcore Prime Biopsy Instrument received FDA 510(k) clearance on 2023-11-29, under 510(k) number K230646.

Who is the listed applicant for SUREcore Prime Biopsy Instrument?

The FDA 510(k) record lists Uro-1 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUREcore Prime Biopsy Instrument?

The FDA product code for SUREcore Prime Biopsy Instrument is KNW.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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, LLCK261196Promisemed 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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