NWW

Hysteroscope Accessories

产品代码

NWW

器械名称

Hysteroscope Accessories

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 884.1690

FDA 专业组

Obstetrics/Gynecology

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

Exempt hysteroscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

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）。