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FDA 510(k)

CoolCryo - 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)

K号: K251928 · 2026-02-13

申请人Medinice S.A.
决定日期2026-02-13
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

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) is the device name listed in this FDA 510(k) record. The listed applicant is Medinice S.A.. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K251928. 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 CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Medinice S.A.. The 510(k) number is K251928.

When did CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) receive FDA 510(k) clearance?

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K251928.

Who is the listed applicant for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

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

What is the FDA product code for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)?

The FDA product code for CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) 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

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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