K250351

Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)

510(k) 号: K250351
器械名称: Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)
申请人: Olympus Medical Systems Corporation JP
产品代码: KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
批准日期: 2025-10-10
受理日期: 2025-02-07
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Gastroenterology, Urology

也可从 FDA 官方下载： K250351.pdf

FDA 官方记录： K250351

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。