SAH
- Product code
- SAH
- Device name
- Magnetic Compression Anastomosis System
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4816
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 8
FDA classification definition
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
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 | — |
Official FDA classification page: SAH
Classification and pathway per current FDA publications. Data from openFDA (CC0).