K260711

Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)

510(k) 号: K260711
器械名称: Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)
申请人: Berkeley Advanced Biomaterials CA · US
产品代码: KGN — Wound Dressing With Animal-Derived Material(S)
批准日期: 2026-08-27
受理日期: 2026-03-05
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: Unknown

510(k) Summary（FDA 官方 PDF）： K260711.pdf

FDA 官方记录： K260711

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。