QLY
- 产品代码
- QLY
- 器械名称
- Ophthalmic 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)
- 7 件
FDA 分类定义
An Ophthalmic Syringe is a piston syringe intended for intraocular injections. The device consists of a calibrated hollow barrel, a movable plunger, and may include a needle. The device should be used by health care professionals to perform injections into the eye.
该代码近三年的 510(k)(5 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K251849 | 2025-11-21 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250L | |
| K243322 | 2025-05-09 | Altaviz, LLC | Altaviz Intravitreal Syringe | |
| K243027 | 2025-04-08 | Hangzhou Sightnovo Medical Technology | Disposable Aqueous Humor Collector (SnovoDAHC I-50, | |
| K243936 | 2025-04-03 | Staclear, Inc. | StaClear Syringe (SC250AN); StaClear Syringe (SC250L | |
| K243149 | 2024-12-20 | Congruence Medical Solutions, LLC | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 1 |
FDA 官方分类页: QLY
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。