NTB

System, Ablation, Ultrasound And Accessories

产品代码

NTB

器械名称

System, Ablation, Ultrasound And Accessories

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.4400

FDA 专业组

General, Plastic Surgery

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 历史累计 510(k)

6 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Intended for use as a surgical tool for coagulation and ablation of soft tissue. This differs from the description in the regulation in that this device is not intended to cut tissue and this device uses high intensity ultrasound energy instead of electrosurgery or electrocautery.

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）。