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FDA 510(k)

吸引閥 (MAJ-1443)；空氣/水閥 (MAJ-1444)

K 號：K250949 · 2025-07-16

申請人Olympus Medical Systems Corporation
決定日期2025-07-16
產品代碼ODC
諮詢委員會GU
決定相當於

器材摘要

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-07-16 under 510(k) number K250949. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K250949.

When did Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) receive FDA 510(k) clearance?

Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) received FDA 510(k) clearance on 2025-07-16, under 510(k) number K250949.

Who is the listed applicant for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

FDA 510(k) 記錄中將Olympus Medical Systems Corporation列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444)?

The FDA product code for Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) is ODC.

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 Olympus Medical Systems Corporation 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。

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查看所有 36 項裝置 →

相關器械（代碼：ODC）

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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