Magnetic Compression Anastomosis System
General, Plastic Surgery · 21 CFR 878.4816
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 MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Gt Metabolic Solutions, Inc.Jun 4, 2026
K253102 · GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
- GI Windows, Inc.Jan 9, 2026
K253550 · Self-Forming Magnet (Flexagon Plus OTOLoc)
- GI Windows, Inc.Aug 1, 2025
K250541 · Self-Forming Magnet (Flexagon Plus OTOLoc)
- GI Windows, Inc.Jun 11, 2025
K243482 · Self-Forming Magnet (Flexagon)
- Gt Metabolic Solutions, Inc.Feb 28, 2025
K243359 · MagDI System (MAG-02, DS-01)
- GI Windows, Inc.Jan 29, 2025
K243213 · Self-Forming Magnet (FLEX SFM)
- Gt Metabolic Solutions, Inc.Oct 24, 2024
K242086 · MagDI System (MAG-01, DS-01)
- Gt Metabolic Solutions, Inc.Jul 2, 2024
DEN240013 · MagDI System