FDA 510(k)

CryoFreeze 疣和皮肤标签去除器

K号: K243487 · 2025-03-13

决定日期2025-03-13

产品代码GEH

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决定实质等同

器械摘要

CryoFreeze Wart and Skin Tag Remover is the device name listed in this FDA 510(k) record. The listed applicant is Cryosurgery, Inc.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K243487. 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 CryoFreeze Wart and Skin Tag Remover?

CryoFreeze Wart and Skin Tag Remover is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Cryosurgery, Inc.. The 510(k) number is K243487.

When did CryoFreeze Wart and Skin Tag Remover receive FDA 510(k) clearance?

CryoFreeze Wart and Skin Tag Remover received FDA 510(k) clearance on 2025-03-13, under 510(k) number K243487.

Who is the listed applicant for CryoFreeze Wart and Skin Tag Remover?

FDA 510(k)记录显示Cryosurgery，Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for CryoFreeze Wart and Skin Tag Remover?

The FDA product code for CryoFreeze Wart and Skin Tag Remover is GEH.

列明Cryosurgery, 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。

K261684冻喷剂 TA K253000CryoFreeze 疣和皮肤标签去除器 K252903疣冷冻H+K243454疣冷冻仪 K233347Verruca-Freeze® H

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 Medical K261068Maverix Cryo Biopsy Probe (MCB1000)；Maverix Cryo Cartridge (CC1000)Serpex Medical K261806ERBECRYO 2 冷冻手术单元及附件Erbe Elektromedizin GmbH K253230ERBECRYO 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 GmbH K252198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

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