FDA 510(k)

Freeze Point & Private Label Versions

K号: K242625 · 2024-10-25

决定日期2024-10-25

产品代码GEH

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决定实质等同

器械摘要

Freeze Point & Private Label Versions is the device name listed in this FDA 510(k) record. The listed applicant is Cryoconcepts LP. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242625. 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 Freeze Point & Private Label Versions?

Freeze Point & Private Label Versions is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Cryoconcepts LP. The 510(k) number is K242625.

When did Freeze Point & Private Label Versions receive FDA 510(k) clearance?

Freeze Point & Private Label Versions received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242625.

Who is the listed applicant for Freeze Point & Private Label Versions?

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

What is the FDA product code for Freeze Point & Private Label Versions?

The FDA product code for Freeze Point & Private Label Versions is GEH.

列明Cryoconcepts LP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。

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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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