K242894

SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)

510(k) 号: K242894
器械名称: SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45)
申请人: Shanghai Saints Sages Surgical Co., Ltd. CN
产品代码: LFL — Instrument, Ultrasonic Surgical
批准日期: 2025-06-18
受理日期: 2024-09-23
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Unknown

PDF下载 510(k) Summary本站存档 · 3.0 MB · FDA 公有领域文件

也可从 FDA 官方下载： K242894.pdf

FDA 官方记录： K242894

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。