FDA 510(k)

Optilume® 高壓泌尿學氣球擴張導尿管

K 號：K250910 · 2025-05-22

決定日期2025-05-22

產品代碼EZN

諮詢委員會GU

決定相當於

器材摘要

Optilume® High Pressure Urological Balloon Dilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K250910. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optilume® High Pressure Urological Balloon Dilation Catheter?

Optilume® High Pressure Urological Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Urotronic, Inc.. The 510(k) number is K250910.

When did Optilume® High Pressure Urological Balloon Dilation Catheter receive FDA 510(k) clearance?

Optilume® High Pressure Urological Balloon Dilation Catheter received FDA 510(k) clearance on 2025-05-22, under 510(k) number K250910.

Who is the listed applicant for Optilume® High Pressure Urological Balloon Dilation Catheter?

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

What is the FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter?

The FDA product code for Optilume® High Pressure Urological Balloon Dilation Catheter is EZN.

其他以 Urotronic, 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。

K191061Optilume Basic 泌尿學氣球擴張導尿管

相關器械（代碼：EZN）

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。

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官方來源

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