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FDA 510(k)

RetroPerc灵活输尿管镜引导逆行肾造瘘钢丝穿刺套装

K号: K160077 · 2016-07-12

申请人Jbw7 Innovations, LLC
决定日期2016-07-12
产品代码LJE
决定实质等同

器械摘要

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is the device name listed in this FDA 510(k) record. The listed applicant is Jbw7 Innovations, LLC. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K160077. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

常见问题

What is the RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Jbw7 Innovations, LLC. The 510(k) number is K160077.

When did RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set receive FDA 510(k) clearance?

RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set received FDA 510(k) clearance on 2016-07-12, under 510(k) number K160077.

Who is the listed applicant for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA 510(k) record lists Jbw7 Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set?

The FDA product code for RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set is LJE.

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：LJE）

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。

K250448一次性经皮肾造口扩张套件Shenzhen Trious Medical Technology Co., Ltd.K222705引入针Youcare Technology Co.,Ltd. (Wuhan)K211911Kolibri 经皮肾造瘘导管，Kolibri 经皮肾造瘘套装，Kolibri 直接穿刺套装Coloplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope 环形肾造口套装，Ultrathane 肾造口套装带 Mac-Loc，Ultrathane 腹股沟套装带 Mac-LocCook IncorporatedK190903Lawson 逆行肾造口钢丝穿刺套装Cook Incorporated

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