NWV
- 产品代码
- NWV
- 器械名称
- Laparoscopic Accessories, Gynecologic
- 管理类别
- 第 1 类（Class I）
- 21 CFR 条款
- 21 CFR 884.1720
- 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 laparoscope accessories are non-powered, non-inflatable, simple manual mechanical devices, e.g., cannula, graspers, forceps, dissectors, scissors, etc. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.
FDA 官方分类页： NWV
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。