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FDA 510(k)

VECTR – 视频内镜腕管减压系统

K号: K242417 · 2024-12-11

申请人Rafael Medical Devices, LLC
决定日期2024-12-11
产品代码HRX
咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。 产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同

器械摘要

VECTR – Video Endoscopic Carpal Tunnel Release System is the device name listed in this FDA 510(k) record. The listed applicant is Rafael Medical Devices, LLC. It received FDA 510(k) clearance on 2024-12-11 under 510(k) number K242417. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VECTR – Video Endoscopic Carpal Tunnel Release System?

VECTR – Video Endoscopic Carpal Tunnel Release System is a medical device that received FDA 510(k) clearance on 2024-12-11. The listed applicant is Rafael Medical Devices, LLC. The 510(k) number is K242417.

When did VECTR – Video Endoscopic Carpal Tunnel Release System receive FDA 510(k) clearance?

VECTR – Video Endoscopic Carpal Tunnel Release System received FDA 510(k) clearance on 2024-12-11, under 510(k) number K242417.

Who is the listed applicant for VECTR – Video Endoscopic Carpal Tunnel Release System?

The FDA 510(k) record lists Rafael Medical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VECTR – Video Endoscopic Carpal Tunnel Release System?

The FDA product code for VECTR – Video Endoscopic Carpal Tunnel Release System is HRX.

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：HRX）

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。

K260203富勒椎体成形术球囊导管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯关节镜望远镜Karl Storz SE & CO. KGK252790数字ClarusScope系统及数字NeuroPEN系统Clarus Medical, LLCK253523Freedom DS®减压系统Spinal SimplicityK252546Vantage™ 腰椎减压套装Allevion Medical, LLCK253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）Medimaging Integrated Solution, Inc (Miis)

官方来源

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