SIR
- 产品代码
- SIR
- 器械名称
- Integrated Operating Table-Electromechanical Surgical System
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4966
- 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)
- 1 件
- 其中 Summary 已存档
- 0 份,可直接下载
- FDA 历史累计 510(k)
- 1 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
An integrated operating table-electromechanical surgical system is a software-controlled electromechanical platform, consisting of a surgical table with integrated robotic arms and table motion capability, that enables a qualified user to perform surgical techniques during minimally invasive and laparoscopic surgical procedures. The surgical table can be used for open surgical procedures independent of the robotic platform.
该代码近三年的 510(k)(1 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| DEN250068 | 2026-07-21 | Auris Health, Inc., part of Johnson & … | OTTAVA Robotic Surgical System | — |
FDA 官方分类页: SIR
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。