FDA 510(k)

UroLift 系统 UL500，UroLift 注射手柄，UroLift 嵌入式胶囊

K号: K162345 · 2016-09-21

决定日期2016-09-21

产品代码PEW

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决定实质等同

器械摘要

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162345. The device is classified under product code PEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Neotract, Inc.. The 510(k) number is K162345.

When did UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge receive FDA 510(k) clearance?

UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162345.

Who is the listed applicant for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

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

What is the FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge?

The FDA product code for UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge is PEW.

列明Neotract, Inc.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。

K232558UroLift 2 ATC 高级组织控制系统 K212396UroLift系统刚性回收套件灭菌托盘 K201837UroLift 2 系统（原名 UL500），UroLift 2 注射手柄，UroLift 2 嵌入式药盒 K200441UroLift高级组织控制（ATC）系统 K192781UroLift系统手术套件灭菌托盘 K193269UroLift系统（UL400）

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官方来源

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