FDA product code SAH: Magnetic Compression Anastomosis System
SAH is the FDA product code for magnetic compression anastomosis system. It is a Class II device, regulated under 21 CFR 878.4816 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under SAH, 8 in the last five years, from 2 different applicants. The average 510(k) review took 144 days (median 128); 133 days on average over the last three years. 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Magnetic Compression Anastomosis System |
| Device class | Class II |
| Regulation | 21 CFR 878.4816 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for SAH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 99 |
| 2025 | 4 | 153 |
| 2026 | 3 | 148 |
Compare with all 510(k) review times · Search every SAH clearance
Top SAH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gt Metabolic Solutions, Inc. | 4 | 2026-09-16 |
| GI Windows, Inc. | 4 | 2026-01-09 |
Most recent SAH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261467 | Gt Metabolic Solutions, Inc. | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | 2026-09-16 | 135 |
| K253102 | Gt Metabolic Solutions, Inc. | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | 2026-06-04 | 253 |
| K253550 | GI Windows, Inc. | Self-Forming Magnet (Flexagon Plus OTOLoc) | 2026-01-09 | 56 |
| K250541 | GI Windows, Inc. | Self-Forming Magnet (Flexagon Plus OTOLoc) | 2025-08-01 | 158 |
| K243482 | GI Windows, Inc. | Self-Forming Magnet (Flexagon) | 2025-06-11 | 215 |
Recalls for SAH devices
openFDA lists no recalls for product code SAH.
Frequently asked questions
What is FDA product code SAH?
SAH is the FDA product code for magnetic compression anastomosis system. It is a Class II device, regulated under 21 CFR 878.4816 and reviewed by the General and Plastic Surgery panel.
What device class is SAH?
Class II, regulation 21 CFR 878.4816. Typical premarket route: 510(k).
How long does a 510(k) take for product code SAH?
Across 8 cleared submissions the average was 144 days from receipt to decision (median 128).
Which companies have the most SAH clearances?
Gt Metabolic Solutions, Inc. (4); GI Windows, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code SAH
- Run a recall and safety report across every SAH manufacturer
- Watch product code SAH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times