SAQ
- 产品代码
- SAQ
- 器械名称
- Electromechanical System For Open Microsurgery
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4963
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 5 件
- 其中 Summary 已存档
- 4 份,可直接下载
- FDA 历史累计 510(k)
- 5 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.
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 |
|---|---|---|---|---|
| K252287 | 2025-11-10 | Medical Microinstruments, Inc. | Symani Surgical System | |
| K251510 | 2025-09-04 | Medical Microinstruments, Inc. | Symani Surgical System | |
| K242368 | 2025-02-07 | Medical Microinstruments, Inc. | Symani Surgical System | |
| K250014 | 2025-01-27 | Medical Microinstruments, Inc. | Symani Surgical System (820-03830) | |
| DEN230032 | 2024-04-05 | Mmi North America, Inc. | Symani Surgical System | — |
FDA 官方分类页: SAQ
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。