K231774

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)

510(k) 号: K231774
器械名称: CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)
申请人: MacroLux Medical Technology Co., Ltd. CN
产品代码: FGB — Ureteroscope And Accessories, Flexible/Rigid
批准日期: 2024-01-11
受理日期: 2023-06-16
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.0 MB · FDA 公有领域文件

也可从 FDA 官方下载： K231774.pdf

FDA 官方记录： K231774

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。