K233778

Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)

510(k) 号: K233778
器械名称: Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
申请人: Zhuhai Pusen Medical Technology Co., Ltd. CN
产品代码: FGB — Ureteroscope And Accessories, Flexible/Rigid
批准日期: 2024-07-16
受理日期: 2023-11-27
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

也可从 FDA 官方下载： K233778.pdf

FDA 官方记录： K233778

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。