GAG
- 产品代码
- GAG
- 器械名称
- Stapler, Surgical
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 878.4740
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 7 件
- 其中 Summary 已存档
- 6 份,可直接下载
- FDA 历史累计 510(k)
- 43 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
该代码近三年的 510(k)(7 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253527 | 2026-07-01 | Covidien, LLC | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thi | |
| K251482 | 2025-07-11 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler | |
| K243596 | 2025-03-10 | Intuitive Surgical, Inc. | da Vinci SP SureForm 45 Staplers and Reloads (SP1098 | |
| K240881 | 2024-11-01 | Covidien (Part of Medtronic) | Signia Circular Adapter (Standard Length) (SIGCIRST | |
| K241629 | 2024-07-03 | Ethicon Endo-Surgery, LLC | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon | |
| K234039 | 2024-05-07 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler (Short/AEPH060); AEO | FDA |
| K231934 | 2023-10-27 | Covidien | GIA Stapler with Tri-Staple Technology |
FDA 官方分类页: GAG
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。