QGD

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

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.

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)。

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。