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FDA 510(k)

CrossBow 腹外斜肌闭合系统，带适配器的CrossBow 腹外斜肌闭合系统

K号: K172666 · 2017-12-01

申请人Sutureease, Inc.
决定日期2017-12-01
产品代码OCW
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Sutureease, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) number K172666. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is a medical device that received FDA 510(k) clearance on 2017-12-01. The listed applicant is Sutureease, Inc.. The 510(k) number is K172666.

When did CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor receive FDA 510(k) clearance?

CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor received FDA 510(k) clearance on 2017-12-01, under 510(k) number K172666.

Who is the listed applicant for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

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

What is the FDA product code for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor?

The FDA product code for CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor is OCW.

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：OCW）

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。

K252400Endomina EZFuse系统Endo Tools Therapeutics S.A.K243750SimpleStitch 缝合系统Envision EndoscopyK231240MaxTack® 电动固定装置CovidienK213271MedicloseTM 系统Health Value Creation B.V., Trading AS Corporis MedicalK231553OverStitch NXT 内窥镜缝合系统Apollo Endosurgery, Inc.K211309endoMina系统Endo Tools Therapeutics S.A.

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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