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FDA 510(k)

ERBECRYO 2 冷冻手术单元；ERBECRYO 2 1-踏板脚踏开关，ERBECRYO 2 脚踏开关延长线；弹性冷冻探头；ERBECRYO 2 手推车，VIO-Cart，铁丝篮；连接软管，切换阀，适配器

K号: K190651 · 2020-01-07

申请人Erbe Elektromedizin GmbH
决定日期2020-01-07
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

ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2020-01-07 under 510(k) number K190651. 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 ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter?

ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter is a medical device that received FDA 510(k) clearance on 2020-01-07. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K190651.

When did ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter receive FDA 510(k) clearance?

ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter received FDA 510(k) clearance on 2020-01-07, under 510(k) number K190651.

Who is the listed applicant for ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter?

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

What is the FDA product code for ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter?

The FDA product code for ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter 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

列明Erbe Elektromedizin GmbH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。

K261806ERBECRYO 2 冷冻手术单元及附件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K253915MOVIVA® 混合消融探头K251108Erbe ESU 型号 VIO® 3n 及附件K243120混合APC探头K243451FiAPC plus探头

查看所有 15 个设备 →

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

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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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