FDA 510(k)

Universa Soft 肾盂输尿管支架及支架套装

K号: K151051 · 2016-01-11

决定日期2016-01-11

产品代码FAD

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决定实质等同

器械摘要

Universa Soft Ureteral Stents and Stent Sets is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-01-11 under 510(k) number K151051. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Universa Soft Ureteral Stents and Stent Sets?

Universa Soft Ureteral Stents and Stent Sets is a medical device that received FDA 510(k) clearance on 2016-01-11. The listed applicant is Cook Incorporated. The 510(k) number is K151051.

When did Universa Soft Ureteral Stents and Stent Sets receive FDA 510(k) clearance?

Universa Soft Ureteral Stents and Stent Sets received FDA 510(k) clearance on 2016-01-11, under 510(k) number K151051.

Who is the listed applicant for Universa Soft Ureteral Stents and Stent Sets?

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

What is the FDA product code for Universa Soft Ureteral Stents and Stent Sets?

The FDA product code for Universa Soft Ureteral Stents and Stent Sets is FAD.

列明Cook Incorporated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。

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相关器械（代码：FAD）

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。

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