FDA 510(k)

疣冷冻H+

K号: K252903 · 2025-10-10

决定日期2025-10-10

产品代码GEH

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决定实质等同

器械摘要

Verruca-Freeze H Plus is the device name listed in this FDA 510(k) record. The listed applicant is Cryosurgery, Inc.. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K252903. 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 Verruca-Freeze H Plus?

Verruca-Freeze H Plus is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Cryosurgery, Inc.. The 510(k) number is K252903.

When did Verruca-Freeze H Plus receive FDA 510(k) clearance?

Verruca-Freeze H Plus received FDA 510(k) clearance on 2025-10-10, under 510(k) number K252903.

Who is the listed applicant for Verruca-Freeze H Plus?

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 Verruca-Freeze H Plus?

The FDA product code for Verruca-Freeze H Plus 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 K243487CryoFreeze 疣和皮肤标签去除器 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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