FDA 510(k)

TopFine® LDS (低死腔) 静脈注射器（2 款型號 (TS-LDS2334, TS-LDS2534))

K 號：K231856 · 2024-03-15

決定日期2024-03-15

產品代碼QNQ

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

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is the device name listed in this FDA 510(k) record. The listed applicant is Medexel Co.,Ltd. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K231856. The device is classified under product code QNQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Medexel Co.,Ltd. The 510(k) number is K231856.

When did TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) receive FDA 510(k) clearance?

TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K231856.

Who is the listed applicant for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

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

What is the FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))?

The FDA product code for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) is QNQ.

其他以 Medexel Co.,Ltd 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。

K172095自動保持器 K152410頂級精細針頭

相關器械（代碼：QNQ）

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。

K252814Profoject™ 低死腔針筒 / Profoject™ 结核菌素針筒；Profoject™ 低死腔針筒（附針）/ Profoject™ 结核菌素針筒（附針）；Profoject™ 低死腔針筒（永久針）/ Profoject™ 结核菌素針筒（永久針）；Profoject™ 低死腔安全針筒 / Profoject™ 结核菌素安全針筒CMT Health PTE., Ltd.K250127TSK 靜脈注射針Tsk Laboratory, Japan K250138小容量0.2毫升針筒Prosum Medical Limited K242291SOL-M Luer Lock 静脈注射器（低死腔）無針頭，SOL-M 滑尖注射器（低死腔）無針頭，SOL-M Luer Lock 静脈注射器（低死腔）可更換針頭，SOL-CARE Luer Lock 静脈注射器（低死腔）配安全針，SOL-M 滑尖注射器（低死腔）可更換針頭Sol-Millennium Medical, Inc.K232943皮下針-Pro® EDGE™ 低死空間針筒安全裝置Smiths Medical Asd, Inc.K241190PLPT LDV（低死腔）LC（Luer-Cone）无菌針筒；PLPT LDV（低死腔）LL（Luer-Lock）无菌針筒Poonglim Pharmatech, Inc.

官方來源

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