SIR

Integrated Operating Table-Electromechanical Surgical System

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.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(1 件)

数据窗口为最近三年。最新一件:2026-07-21。

510(k) 号批准日期申请人器械名称摘要
DEN2500682026-07-21Auris 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。