QGA

Penile Implant Surgical Accessories

产品代码: QGA
器械名称: Penile Implant Surgical Accessories
管理类别: 第 1 类（Class I）
21 CFR 条款: 21 CFR 876.3500
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

Penile implant surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of a penile inflatable implant or penile rigidity implant. This generic type of device includes the cylinder sizer, cylinder insertion tool and needle, device placement tool, connector assembly tool, incision closing tool, corporeal dilator, tubing passer, measurement tool or tape, tubing plug, 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： QGA

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。