K241629
- 510(k) 号
- K241629
- 器械名称
- ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
- 申请人
- Ethicon Endo-Surgery, LLC PR
- 产品代码
- GAG — Stapler, Surgical
- 批准日期
- 2024-07-03
- 受理日期
- 2024-06-06
- 决定
- Substantially Equivalent
- 审查途径
- Special
- 咨询委员会
- General Hospital
FDA 官方记录: K241629
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。