K252703

LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

510(k) 号: K252703
器械名称: LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)
申请人: Boston Scientific Corporation MA · US
产品代码: FGB — Ureteroscope And Accessories, Flexible/Rigid
批准日期: 2025-09-24
受理日期: 2025-08-27
决定: Substantially Equivalent
审查途径: Special
咨询委员会: Gastroenterology, Urology

PDF下载 510(k) Summary本站存档 · 1.1 MB · FDA 公有领域文件

也可从 FDA 官方下载： K252703.pdf

FDA 官方记录： K252703

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。