SAH
8 FDA 510(k) clearances · Product code
122 daysmedian time to decision
253 days90th percentile
8clearances measured
FDA profile
- Official device name
- Magnetic Compression Anastomosis System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4816
- Medical specialty
- General, Plastic Surgery
- FDA 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (K253102) | Gt Metabolic Solutions, Inc. | 2026-06-04 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K253550) | GI Windows, Inc. | 2026-01-09 |
| Self-Forming Magnet (Flexagon Plus OTOLoc) (K250541) | GI Windows, Inc. | 2025-08-01 |
| Self-Forming Magnet (Flexagon) (K243482) | GI Windows, Inc. | 2025-06-11 |
| MagDI System (MAG-02, DS-01) (K243359) | Gt Metabolic Solutions, Inc. | 2025-02-28 |
| Self-Forming Magnet (FLEX SFM) (K243213) | GI Windows, Inc. | 2025-01-29 |
| MagDI System (MAG-01, DS-01) (K242086) | Gt Metabolic Solutions, Inc. | 2024-10-24 |
| MagDI System (DEN240013) | Gt Metabolic Solutions, Inc. | 2024-07-02 |
Track SAH automatically
Every clearance here is in the API, with alerts when new ones post.