K250945

Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)

510(k) 号: K250945
器械名称: Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
申请人: Olympus Medical Systems Corp. JP
产品代码: KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
批准日期: 2025-10-17
受理日期: 2025-03-28
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 · 1.2 MB · FDA 公有领域文件

也可从 FDA 官方下载： K250945.pdf

FDA 官方记录： K250945

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。