QXG

Cooperative Powered Surgical Assist Device For Ent Surgery

产品代码: QXG
器械名称: Cooperative Powered Surgical Assist Device For Ent Surgery
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 874.4460
FDA 专业组: Ear, Nose, Throat
上市路径: 需提交 510(k) 上市前通告
FDA 历史累计 510(k): 1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery is a device that facilitates ENT surgical procedures, including instrument placement. The device works in conjunction with the surgeon's movements to assist with precise and stable positioning of an instrument while maintaining the surgeons direct physical control of the instrument.

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： QXG

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。