QSM
- 产品代码
- QSM
- 器械名称
- System, Surgical, Computer Controlled Instrument, Remanufactured
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 876.1500
- FDA 专业组
- Gastroenterology, Urology
- 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
- 6 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
As intended with the originally cleared instrument.
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 |
|---|---|---|---|---|
| K252926 | 2026-03-26 | Restore Robotics | Robotic Surgical Instruments - Permanent Cautery Hoo | |
| K250417 | 2025-08-20 | Rebotix | Remanufactured EndoWrist Cobra Grasper (420190) | |
| K250539 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Tenaculum Forceps (420207) | |
| K250399 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Cadiere Forceps (420049) | |
| K250387 | 2025-08-19 | Rebotix | Remanufactured EndoWrist Long Tip Forceps (420048) | FDA |
| K242610 | 2025-03-11 | Iconocare Health | 8mm Monopolar Curved Scissors (470179) | |
| K241872 | 2024-11-07 | Rebotix | Remanufactured EndoWrist ProGrasp Forceps (420093) |
FDA 官方分类页: QSM
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。