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FDA 510(k)

SchurSign组织标记

K号: K230836 · 2024-01-23

申请人Surgmark GmbH
决定日期2024-01-23
产品代码NEU
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

SchurSign Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Surgmark GmbH. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K230836. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SchurSign Tissue Marker?

SchurSign Tissue Marker is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Surgmark GmbH. The 510(k) number is K230836.

When did SchurSign Tissue Marker receive FDA 510(k) clearance?

SchurSign Tissue Marker received FDA 510(k) clearance on 2024-01-23, under 510(k) number K230836.

Who is the listed applicant for SchurSign Tissue Marker?

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

What is the FDA product code for SchurSign Tissue Marker?

The FDA product code for SchurSign Tissue Marker is NEU.

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：NEU）

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。

K253761HydroMARK™ Plus 乳腺活检位点标记（蜻蜓形状）；HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）Devicor Medical Products, Inc.K253888MOLLI 2 系统Stryker EndoscopyK252892SCOUT MD 外科引导系统Merit Medical Systems, Inc.K251989VizMark 预装组织标记器设备（VM-0001）Breast-Med, Inc.K251748MammoSTAR活检位点标识器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳腺组织标记器Bard Peripheral Vascular, Inc.

官方来源

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