SAB
- 产品代码
- SAB
- 器械名称
- Table Mounted Miniaturized Electromechanical Surgical System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4962
- 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)
- 2 件
- 其中 Summary 已存档
- 1 份,可直接下载
- FDA 历史累计 510(k)
- 2 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms
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 |
|---|---|---|---|---|
| K260817 | 2026-08-20 | Virtual Incision | MIRA Surgical System | |
| DEN230025 | 2024-02-23 | Virtual Incision | MIRA Surgical System | — |
FDA 官方分类页: SAB
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。