SAH
- 产品代码
- SAH
- 器械名称
- Magnetic Compression Anastomosis System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4816
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 8 件
- 其中 Summary 已存档
- 7 份，可直接下载
- FDA 历史累计 510(k)
- 8 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
A magnetic compression anastomosis system is a surgical device used for the creation of anastomoses in minimally invasive and laparoscopic surgery in the gastrointestinal tract. The system is comprised of magnet devices and may involve a delivery system. Compression and necrosis of tissue between magnet devices is created by polar attraction of the magnet devices with healing of tissue around the devices. Once the anastomosis is formed, the magnet devices are expelled naturally. This classification does not include devices intended for weight loss or metabolic disease treatment
该代码近三年的 510(k)（8 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253102 | 2026-06-04 | Gt Metabolic Solutions, Inc. | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | |
| K253550 | 2026-01-09 | GI Windows, Inc. | Self-Forming Magnet (Flexagon Plus OTOLoc) | |
| K250541 | 2025-08-01 | GI Windows, Inc. | Self-Forming Magnet (Flexagon Plus OTOLoc) | |
| K243482 | 2025-06-11 | GI Windows, Inc. | Self-Forming Magnet (Flexagon) | |
| K243359 | 2025-02-28 | Gt Metabolic Solutions, Inc. | MagDI System (MAG-02, DS-01) | |
| K243213 | 2025-01-29 | GI Windows, Inc. | Self-Forming Magnet (FLEX SFM) | |
| K242086 | 2024-10-24 | Gt Metabolic Solutions, Inc. | MagDI System (MAG-01, DS-01) | |
| DEN240013 | 2024-07-02 | Gt Metabolic Solutions, Inc. | MagDI System | — |
FDA 官方分类页： SAH
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。