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FDA 510(k)

Pledgeted COR-SUTURE QUICK LOAD

K号: K160529 · 2016-09-15

申请人Lsi Soultions
决定日期2016-09-15
产品代码GAW
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

Pledgeted COR-SUTURE QUICK LOAD is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Soultions. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160529. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pledgeted COR-SUTURE QUICK LOAD?

Pledgeted COR-SUTURE QUICK LOAD is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Lsi Soultions. The 510(k) number is K160529.

When did Pledgeted COR-SUTURE QUICK LOAD receive FDA 510(k) clearance?

Pledgeted COR-SUTURE QUICK LOAD received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160529.

Who is the listed applicant for Pledgeted COR-SUTURE QUICK LOAD?

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

What is the FDA product code for Pledgeted COR-SUTURE QUICK LOAD?

The FDA product code for Pledgeted COR-SUTURE QUICK LOAD is GAW.

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：GAW）

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。

K253572STRATAFIX® 螺旋 PRONOVA® 单向无结组织控制装置 STRATAFIX® 螺旋 PRONOVA® 双向无结组织控制装置ETHICON, Inc.K233355Cypris eXact缝合系统Cypris MedicalK230746不可吸收性外科聚丙烯缝合线Shandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH 网状缝合线MsiK192953APTOS 线 - 聚丙烯手术缝合线Aptos, LLC

官方来源

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