FDA 510(k)

pAguaMedicina 持久性结构型水凝胶输尿管支架

K号: K172289 · 2017-10-04

决定日期2017-10-04

产品代码FAD

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决定实质等同

器械摘要

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Q Urological Corporation. It received FDA 510(k) clearance on 2017-10-04 under 510(k) number K172289. 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 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is a medical device that received FDA 510(k) clearance on 2017-10-04. The listed applicant is Q Urological Corporation. The 510(k) number is K172289.

When did pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent receive FDA 510(k) clearance?

pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent received FDA 510(k) clearance on 2017-10-04, under 510(k) number K172289.

Who is the listed applicant for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

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

What is the FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent?

The FDA product code for pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent is FAD.

列明Q Urological Corporation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。

K163068pAguaMedicina 持久性结构型水凝胶输尿管支架

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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