K261897

HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology

510(k) 号: K261897
器械名称: HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology
申请人: O&M Halyard, Inc. GA · US
产品代码: FRG — Wrap, Sterilization
批准日期: 2026-07-02
受理日期: 2026-06-05
决定: Substantially Equivalent
审查途径: Traditional
标记: 第三方审查
咨询委员会: General Hospital

510(k) Summary（FDA 官方 PDF）： K261897.pdf

FDA 官方记录： K261897

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。