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FDA 510(k)

LDS針；OcuSafe® LDS針；SteriCap® LDS安全針；VitreJect® LDS安全針

K 號：K242956 · 2024-10-25

申請人Ocuject, LLC
決定日期2024-10-25
產品代碼QNS
諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ocuject, LLC. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242956. The device is classified under product code QNS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Ocuject, LLC. The 510(k) number is K242956.

When did LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle receive FDA 510(k) clearance?

LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242956.

Who is the listed applicant for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

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

What is the FDA product code for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle?

The FDA product code for LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle is QNS.

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 Ocuject, LLC 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。

K233343斯泰里卡普安全針；維特雷克安全針K230959VitreJect®針頭；OcuSafe®針頭K230372維特賈克針筒K212544迷你載量針筒K212805醫療設備名稱：SteriCap Mini針頭和標準針頭K202432迷你載量針筒

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相關器械（代碼：QNS）

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。

K231734STERiJECT 低死腔，STERiJECT 無形針Tsk Laboratory International Japan KKK210444EZ-Injec LDV 無菌安全針Poonglim Pharmatech, Inc.

官方來源

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