QNM
- 产品代码
- QNM
- 器械名称
- Mountable Electromechanical Surgical System For Transluminal Approaches
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4961
- 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)
- 7 件
- 其中 Summary 已存档
- 7 份,可直接下载
- FDA 历史累计 510(k)
- 8 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.
该代码近三年的 510(k)(7 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K251761 | 2025-07-08 | Momentis Surgical , Ltd. | Anovo Surgical System (Model 6Ne); Anovo Instrument … | |
| K250591 | 2025-06-06 | Momentis Surgical , Ltd. | Anovo Surgical System (6Ne) | |
| K251056 | 2025-05-02 | Momentis Surgical , Ltd. | Anovo Instrument ARM Curved Scissors ; Anovo Instrum… | |
| K243182 | 2025-02-03 | Momentis Surgical , Ltd. | Anovo Instrument ARM Curved Scissors; Anovo Instrume… | |
| K242157 | 2024-10-21 | Momentis Surgical , Ltd. | Anovo Surgical System (Model 6Ne) | |
| K241907 | 2024-10-02 | Momentis Surgical , Ltd. | Anovo Surgical System (model 6N) | |
| K232146 | 2023-09-14 | Momentis Surgical , Ltd. | Anovo Pedestal |
FDA 官方分类页: QNM
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。