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FDA 510(k)

MODEL P8400 C2DX’s Hemostatix 热刀系统控制器

K号: K233185 · 2023-10-24

申请人C2dx, Inc.
决定日期2023-10-24
产品代码GEI
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

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is the device name listed in this FDA 510(k) record. The listed applicant is C2dx, Inc.. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K233185. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is C2dx, Inc.. The 510(k) number is K233185.

When did MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System receive FDA 510(k) clearance?

MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System received FDA 510(k) clearance on 2023-10-24, under 510(k) number K233185.

Who is the listed applicant for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA 510(k) record lists C2dx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System?

The FDA product code for MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System is GEI.

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：GEI）

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLCK261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker InstrumentsK261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364艾利安谜团射频设备Ellian CorpK253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

官方来源

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