K260196
- 510(k) 号
- K260196
- 器械名称
- ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON Circular Stapler (CDH29mm); ETHICON Circular Stapler (CDH33mm); ETHICON Circular Stapler - XL Sealed (ECS21mm); ETHICON Circular Stapler - XL Sealed (ECS25mm); ETHICON Circular Stapler - XL Sealed (ECS29mm); ETHICON Circular Stapler - XL Sealed (ECS33mm)
- 申请人
- Ethicon Endo-Surgery, LLC PR · US
- 产品代码
- GDW — Staple, Implantable
- 批准日期
- 2026-05-11
- 受理日期
- 2026-01-22
- 决定
- Substantially Equivalent
- 审查途径
- Traditional
- 咨询委员会
- General, Plastic Surgery
FDA 官方记录: K260196
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。