GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
Device Facts
| Record ID | K253102 |
|---|---|
| Device Name | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) |
| Applicant | Gt Metabolic Solutions, Inc. |
| Product Code | SAH · General, Plastic Surgery |
| Decision Date | Jun 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4816 |
| Device Class | Class 2 |
Regulatory Classification
Identification
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. The MagDI System is specifically indicated for use in the creation of side-to-side duodeno-ileal anastomoses in adult patients > 21 years.
Special Controls
In combination with the general controls of the FD&C Act, the magnetic compression anastomosis system is subject to the following special controls:
