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FDA 510(k)

SpeedStitch 缝线传递器；SpeedStitch 缝线弹匣，白色缝线，蓝色编织，黑色编织，混合包装；SpeedStitch 针加载器和卸载器

K号: K163142 · 2017-01-06

申请人ArthroCare Corporation
决定日期2017-01-06
产品代码GAT
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

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K163142. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is ArthroCare Corporation. The 510(k) number is K163142.

When did SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader receive FDA 510(k) clearance?

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader received FDA 510(k) clearance on 2017-01-06, under 510(k) number K163142.

Who is the listed applicant for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

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

What is the FDA product code for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader?

The FDA product code for SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is GAT.

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ArthroCare Corporation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。

K254122FLOW FLEXTEND Wand (72290039)K253680LYNX COBLATION Laryngeal Wand (72290254)K240964FLOW 90? WandK232290INTELLIO SHIFT 系统K230914ARIS¿ COBLATION¿ 鼻甲缩减棒（72290113）；WEREWOLF COBLATION 系统（72290144）；WEREWOLF+ COBLATION 系统（72290146）K220563Ambient HipVac 50 手杖带集成手指开关, RF20000 COBLATION 系统, WEREWOLF COBLATION 系统, WEREWOLF+ COBLATION 系统

查看所有 17 个设备 →

相关器械（代码：GAT）

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。

K253910Stitch - 缝线钢丝和胶带GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip系列Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯OrthoTape™Teleflex Medical, LLCK254275HyperSuture全绿色延长线Threadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145预缝合肌腱Rti Surgical, Inc.

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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