FDA 510(k)

UroLift系统手术套件灭菌托盘

K号: K192781 · 2020-04-14

决定日期2020-04-14

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

UroLift System Procedure Kit Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is Neotract, Inc.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K192781. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UroLift System Procedure Kit Sterilization Tray?

UroLift System Procedure Kit Sterilization Tray is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Neotract, Inc.. The 510(k) number is K192781.

When did UroLift System Procedure Kit Sterilization Tray receive FDA 510(k) clearance?

UroLift System Procedure Kit Sterilization Tray received FDA 510(k) clearance on 2020-04-14, under 510(k) number K192781.

Who is the listed applicant for UroLift System Procedure Kit Sterilization Tray?

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 Procedure Kit Sterilization Tray?

The FDA product code for UroLift System Procedure Kit Sterilization Tray is KCT.

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 K193269UroLift系统（UL400）K190377UroLift系统 UL400

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官方来源

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