FDA 510(k)

TopFine® 低残留空间（LDS）注射器（2款型号（TS-LDS2334，TS-LDS2534））

K号: K231856 · 2024-03-15

决定日期2024-03-15

产品代码QNQ

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Medexel Co.,Ltd为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K172095Autokeeper K152410顶级精细笔式针

相关器械（代码：QNQ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K252814Profoject™ 低死腔注射器 /Profoject™ 结核菌素注射器；Profoject™ 低死腔注射器带针 /Profoject™ 结核菌素注射器带针；Profoject™ 低死腔注射器带永久针 /Profoject™ 结核菌素注射器带永久针；Profoject™ 低死腔安全注射器 /Profoject™ 结核菌素安全注射器CMT Health PTE., Ltd.K250127TSK 注射器Tsk Laboratory, Japan K250138小型0.2mL注射器Prosum Medical Limited K242291SOL-M Luer Lock注射器（无针，低残留空间），SOL-M滑尖注射器（无针，低残留空间），SOL-M Luer Lock注射器（低残留空间，可更换针头），SOL-CARE Luer Lock注射器（低残留空间，带安全针），SOL-M滑尖注射器（低残留空间，可更换针头）Sol-Millennium Medical, Inc.K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.K241190PLPT LDV（低残留体积）LC（Luer-Cone）无菌注射器；PLPT LDV（低残留体积）LL（Luer-Lock）无菌注射器Poonglim Pharmatech, Inc.

官方来源

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