QNS
- 产品代码
- QNS
- 器械名称
- Low Dead Space Needle, Single Lumen, Hypodermic
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 880.5570
- 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)
- 3 件
FDA 分类定义
A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. 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)(2 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K242956 | 2024-10-25 | Ocuject, LLC | LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safet | |
| K231734 | 2024-03-08 | Tsk Laboratory International Japan KK | STERiJECT Low Dead Space, STERiJECT The Invisible Ne |
FDA 官方分类页: QNS
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。