FDA 510(k)

Urocross 扩张系统（型号编号 ES2018 和 ES3025）

K号: K253525 · 2026-03-12

决定日期2026-03-12

产品代码QKA

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决定实质等同

器械摘要

Urocross Expander System (Model Numbers ES2018 and ES3025) is the device name listed in this FDA 510(k) record. The listed applicant is Prodeon Medical, Inc.. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K253525. The device is classified under product code QKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Urocross Expander System (Model Numbers ES2018 and ES3025)?

Urocross Expander System (Model Numbers ES2018 and ES3025) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Prodeon Medical, Inc.. The 510(k) number is K253525.

When did Urocross Expander System (Model Numbers ES2018 and ES3025) receive FDA 510(k) clearance?

Urocross Expander System (Model Numbers ES2018 and ES3025) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K253525.

Who is the listed applicant for Urocross Expander System (Model Numbers ES2018 and ES3025)?

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

What is the FDA product code for Urocross Expander System (Model Numbers ES2018 and ES3025)?

The FDA product code for Urocross Expander System (Model Numbers ES2018 and ES3025) is QKA.

列明Prodeon Medical, 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。

K261342Urocross 扩张系统（UES-2018-C1）K252572Prodeon 尿道套管系统

官方来源

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