SAH — Magnetic Compression Anastomosis System Class II
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 |
|---|---|---|---|
| K253550 | gi windows | Self-Forming Magnet (Flexagon Plus OTOLoc) | January 9, 2026 |
| K250541 | gi windows | Self-Forming Magnet (Flexagon Plus OTOLoc) | August 1, 2025 |
| K243482 | gi windows | Self-Forming Magnet (Flexagon) | June 11, 2025 |
| K243359 | gt metabolic solutions | MagDI System (MAG-02, DS-01) | February 28, 2025 |
| K243213 | gi windows | Self-Forming Magnet (FLEX SFM) | January 29, 2025 |
| K242086 | gt metabolic solutions | MagDI System (MAG-01, DS-01) | October 24, 2024 |
| DEN240013 | gt metabolic solutions | MagDI System | July 2, 2024 |