QYK
- 产品代码
- QYK
- 器械名称
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4795
- 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
A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns.
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 |
|---|---|---|---|---|
| DEN210049 | 2024-03-27 | Medline Industries, Inc. | Medline ART Skin Harvesting System | — |
FDA 官方分类页: QYK
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。