XSense冷冻消融系统，配备冷冻探头
K号: K260377 · 2026-02-24
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决定日期2026-02-24
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
XSense Cryoablation System with CryoProbes is the device name listed in this FDA 510(k) record. The listed applicant is IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2026-02-24 under 510(k) number K260377. 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 XSense Cryoablation System with CryoProbes?
XSense Cryoablation System with CryoProbes is a medical device that received FDA 510(k) clearance on 2026-02-24. The listed applicant is IceCure Medical , Ltd.. The 510(k) number is K260377.
When did XSense Cryoablation System with CryoProbes receive FDA 510(k) clearance?
XSense Cryoablation System with CryoProbes received FDA 510(k) clearance on 2026-02-24, under 510(k) number K260377.
Who is the listed applicant for XSense Cryoablation System with CryoProbes?
The FDA 510(k) record lists IceCure Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for XSense Cryoablation System with CryoProbes?
The FDA product code for XSense Cryoablation System with CryoProbes 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IceCure Medical , Ltd.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.K251928CoolCryo - 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)Medinice S.A.
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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