QGD
- 产品代码
- QGD
- 器械名称
- Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
- 管理类别
- 第 1 类(Class I)
- 21 CFR 条款
- 21 CFR 876.5290
- FDA 专业组
- Gastroenterology, Urology
- 上市路径
- 豁免 510(k)(仍须遵守通用控制与注册列名)
FDA 分类定义
Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.
FDA 官方分类页: QGD
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。