K253531

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

510(k) 号: K253531
器械名称: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
申请人: Applied Medical Resources Corporation CA · US
产品代码: KGW — Ring (Wound Protector), Drape Retention, Internal
批准日期: 2026-02-23
受理日期: 2025-11-13
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

也可从 FDA 官方下载： K253531.pdf

FDA 官方记录： K253531

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。