FDA 510(k)

UroLift系统（UL400和UL500）

K号: K173087 · 2017-12-28

决定日期2017-12-28

产品代码PEW

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

UroLift System (UL400 and UL500) is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2017-12-28 under 510(k) number K173087. 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 (UL400 and UL500)?

UroLift System (UL400 and UL500) is a medical device that received FDA 510(k) clearance on 2017-12-28. The listed applicant is Neotract, Inc.. The 510(k) number is K173087.

When did UroLift System (UL400 and UL500) receive FDA 510(k) clearance?

UroLift System (UL400 and UL500) received FDA 510(k) clearance on 2017-12-28, under 510(k) number K173087.

Who is the listed applicant for UroLift System (UL400 and UL500)?

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 (UL400 and UL500)?

The FDA product code for UroLift System (UL400 and UL500) 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）

查看所有 11 个设备 →

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。