SAH — Magnetic Compression Anastomosis System Class II
FDA product code SAH covers "Magnetic Compression Anastomosis System", a Class II medical device regulated under 21 CFR 878.4816. Submissions are reviewed by the General, Plastic Surgery panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAH
- Device Class
- Class II
- Regulation Number
- 878.4816
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261467 | Gt Metabolic Solutions | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS | Sep 16, 2026 |
| K253102 | Gt Metabolic Solutions | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Jun 4, 2026 |
| K253550 | Gi Windows | Self-Forming Magnet (Flexagon Plus OTOLoc) | Jan 9, 2026 |
| K250541 | Gi Windows | Self-Forming Magnet (Flexagon Plus OTOLoc) | Aug 1, 2025 |
| K243482 | Gi Windows | Self-Forming Magnet (Flexagon) | Jun 11, 2025 |
| K243359 | Gt Metabolic Solutions | MagDI System (MAG-02, DS-01) | Feb 28, 2025 |
| K243213 | Gi Windows | Self-Forming Magnet (FLEX SFM) | Jan 29, 2025 |
| K242086 | Gt Metabolic Solutions | MagDI System (MAG-01, DS-01) | Oct 24, 2024 |
| DEN240013 | Gt Metabolic Solutions | MagDI System | Jul 2, 2024 |