QNQ
- 产品代码
- QNQ
- 器械名称
- Low Dead Space Piston Syringe
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5860
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 12 件
FDA 分类定义
A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.
该代码近三年的 510(k)（8 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K252814 | 2026-02-19 | CMT Health PTE., Ltd. | Profoject Low Dead Space Syringe /Profoject Tuberc | |
| K250127 | 2025-07-30 | Tsk Laboratory, Japan | TSK Syringe | |
| K250138 | 2025-04-02 | Prosum Medical Limited | Small Volume 0.2mL Syringe | |
| K242291 | 2024-11-20 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, | |
| K232943 | 2024-05-31 | Smiths Medical Asd, Inc. | Hypodermic Needle-Pro® EDGE Safety Device with Low | FDA |
| K241190 | 2024-05-29 | Poonglim Pharmatech, Inc. | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syri | |
| K231856 | 2024-03-15 | Medexel Co.,Ltd | TopFine® LDS (Low Dead Space) Syringe (2 models (TS- | |
| K221860 | 2023-09-15 | Poonglim Pharmatech, Inc. | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syri |
FDA 官方分类页： QNQ
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。