FDA 510(k)

MiniLap 系统（带 MiniGrip 把手），MiniLap 系统（带拇指握把）

K号: K172775 · 2018-02-12

决定日期2018-02-12

产品代码OCW

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

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2018-02-12 under 510(k) number K172775. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is a medical device that received FDA 510(k) clearance on 2018-02-12. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K172775.

When did MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle receive FDA 510(k) clearance?

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle received FDA 510(k) clearance on 2018-02-12, under 510(k) number K172775.

Who is the listed applicant for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

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

What is the FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle?

The FDA product code for MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle is OCW.

列明Teleflexmedical, 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。

K232469Rüsch 橡胶金 Foley 导尿管 K212077Teleflex Rusch SoftSimplastic Foley 导尿管 K192324Sheridan 螺旋柔性气管插管 K182847Hudson RCI Voldyne 体积训练器 K181979Rusch FloCath 快速 18 Fr. 弯曲型亲水间歇性导管 K183461Rusch 亲水间歇性导管，Rusch MMG 亲水间歇性导管

查看所有 19 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。