FDA 510(k)

Urocross 扩張系統（型號編號 ES2018 及 ES3025）

K 號：K253525 · 2026-03-12

決定日期2026-03-12

產品代碼QKA

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Prodeon Medical, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261342Urocross 扩張系統 (UES-2018-C1)K252572Prodeon 尿道套系

相關器械（代碼：QKA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261342Urocross 扩張系統 (UES-2018-C1)Prodeon Medical, Inc.K210138iTind 系統Medi-Tate , Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。