FDA 510(k)

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe

K号: K232943 · 2024-05-31

决定日期2024-05-31

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

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232943. 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 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K232943.

When did Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe receive FDA 510(k) clearance?

Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232943.

Who is the listed applicant for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

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

What is the FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe?

The FDA product code for Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe is QNQ.

列明Smiths Medical Asd, Inc.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。

K210833Portex BLUxl 长型气管切开管，BLUxl 吸痰辅助长型气管切开管，BLUxl 长型气管切开管内芯 K211634Hypodermic Needle-Pro EDGE Safety Device K192375Intellifuse给药和Intellifuse血液给药套装 K181699Level 1对流加热器 K172800Portex® Lancet Point 脊髓穿刺针带NRFit®连接器，Portex® Pencil Point 脊髓穿刺针带NRFit®连接器 K172823Portex NRFit 蛛网膜下腔穿刺针

查看所有 16 个设备 →

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.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.K231856TopFine® 低残留空间（LDS）注射器（2款型号（TS-LDS2334，TS-LDS2534））Medexel Co.,Ltd

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。