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FDA 510(k)

高级冷冻皮肤疣去除器（高级皮肤疣去除器）

K号: K252198 · 2026-04-02

申请人Medical Brands Laboratories B.V.
决定日期2026-04-02
产品代码GEH
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

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Brands Laboratories B.V.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252198. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Medical Brands Laboratories B.V.. The 510(k) number is K252198.

When did Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) receive FDA 510(k) clearance?

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252198.

Who is the listed applicant for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

The FDA 510(k) record lists Medical Brands Laboratories B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

The FDA product code for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is GEH.

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

列明Medical Brands Laboratories B.V.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。

K242288高级冷冻疣去除器

相关器械（代码：GEH）

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。

K262420Maverix冷冻活检Pro（MCB Pro）（MCBP-1000）；Maverix冷冻胶囊（CC-1000）Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000)；Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 冷冻手术单元及附件Erbe Elektromedizin GmbHK253230ERBECRYO 2 冷冻手术单元及附件：ERBECRYO 2 冷冻手术单元；Erbe 弹性冷冻探头Erbe Elektromedizin GmbHK260377XSense冷冻消融系统，配备冷冻探头IceCure Medical , Ltd.K251928CoolCryo - 心脏冷冻消融用冷冻敷贴器 (CC01-01)；CoolCryo - 带液氮储罐的心脏冷冻消融控制台 (CC01-21)Medinice S.A.

官方来源

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