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FDA 510(k)

Glean 腹腔內視鏡系統男性輸送系統（GUS-1000-M）；Glean 腹腔內視鏡系統女性輸送系統（GUS-1000-F）；Glean 腹腔內視鏡系統尿流計（UFM-1000（尿流計））

K 號：K243052 · 2025-03-24

申請人Bright Uro, Inc.
決定日期2025-03-24
產品代碼EXQ
諮詢委員會GU
決定相當於

器材摘要

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is the device name listed in this FDA 510(k) record. The listed applicant is Bright Uro, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243052. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Bright Uro, Inc.. The 510(k) number is K243052.

When did Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) receive FDA 510(k) clearance?

Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243052.

Who is the listed applicant for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

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

What is the FDA product code for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))?

The FDA product code for Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) is EXQ.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Bright Uro, 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。

K253537Glean 膀胱動力學系統男性輸送系統（GUS-1000-M）；Glean 膀胱動力學系統女性輸送系統（GUS-1000-F）；Glean 膀胱動力學系統尿流計（UFM-1000（尿流計））；Glean 膀胱動力學系統腹部感應器（GUS-1000-A）

相關器械（代碼：EXQ）

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。

K253537Glean 膀胱動力學系統男性輸送系統（GUS-1000-M）；Glean 膀胱動力學系統女性輸送系統（GUS-1000-F）；Glean 膀胱動力學系統尿流計（UFM-1000（尿流計））；Glean 膀胱動力學系統腹部感應器（GUS-1000-A）Bright Uro, Inc.

官方來源

在 FDA 資料庫中查看 →

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