FDA 510(k)

导尿管 12Fr，导尿管 16Fr

K号: K211032 · 2021-11-19

决定日期2021-11-19

产品代码KOD

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决定实质等同

器械摘要

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Urogen Pharma, Ltd.. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211032. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Urogen Pharma, Ltd.. The 510(k) number is K211032.

When did Urinary Catheter 12 Fr, Urinary Catheter 16 Fr receive FDA 510(k) clearance?

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211032.

Who is the listed applicant for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

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

What is the FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr?

The FDA product code for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr is KOD.

列明Urogen Pharma, Ltd.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。

K203321Cystoject注射器杠杆 K190987Uroject12 注射器杠杆 K180354UroGen 肾盂输尿管导管 K180345Uroject12 注射器杠杆

官方来源

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