Dr. Yglo疣去除器
K号: K210529 · 2021-05-06
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决定日期2021-05-06
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
Dr. Yglo Wart Remover is the device name listed in this FDA 510(k) record. The listed applicant is Theotclab Healthcare B.V.. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K210529. 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 Dr. Yglo Wart Remover?
Dr. Yglo Wart Remover is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Theotclab Healthcare B.V.. The 510(k) number is K210529.
When did Dr. Yglo Wart Remover receive FDA 510(k) clearance?
Dr. Yglo Wart Remover received FDA 510(k) clearance on 2021-05-06, under 510(k) number K210529.
Who is the listed applicant for Dr. Yglo Wart Remover?
The FDA 510(k) record lists Theotclab Healthcare B.V. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dr. Yglo Wart Remover?
The FDA product code for Dr. Yglo Wart 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。
列明Theotclab Healthcare 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。
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 GmbHK252198高级冷冻皮肤疣去除器（高级皮肤疣去除器）Medical Brands Laboratories B.V.K260377XSense冷冻消融系统，配备冷冻探头IceCure Medical , Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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