SAH · Magnetic Compression Anastomosis System
General, Plastic Surgery · 21 CFR 878.4816 · Class 2
Overview
| Product Code | SAH |
|---|---|
| Device Name | Magnetic Compression Anastomosis System |
| Regulation | 21 CFR 878.4816 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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.
Classification Rationale
Class II (special controls). The device is classified as Class II because it is a surgical device that requires special controls to provide reasonable assurance of safety and effectiveness, including clinical performance testing, postmarket surveillance, and specific labeling requirements to mitigate risks such as internal hernia, bowel obstruction, and tissue damage.
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:
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | Jan 9, 2026 | SESE |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | Aug 1, 2025 | SESE |
| K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | Jun 11, 2025 | SESE |
| K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | Feb 28, 2025 | SESE |
| K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | Jan 29, 2025 | SESE |
| K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | Oct 24, 2024 | SESE |
| DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | Jul 2, 2024 | DENG |
Top Applicants
- GI Windows, Inc. — 4 clearances
- Gt Metabolic Solutions, Inc. — 3 clearances
