Product code SAH— General, Plastic Surgery
Self-Forming Magnet (Flexagon Plus OTOLoc)
- Classification name
- Magnetic Compression Anastomosis System
- Device class
- Class 2
- Regulation
- 21 CFR 878.4816
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 8
- First cleared
- Most recent
FDA classification 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”
Market context for product code SAH
FDA has cleared devices under product code SAH between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2024
Top applicants under product code SAH
Recent clearances under product code SAH
- K253102 — GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
- K253550 — Self-Forming Magnet (Flexagon Plus OTOLoc)
- K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc)
- K243482 — Self-Forming Magnet (Flexagon)
- K243359 — MagDI System (MAG-02, DS-01)
- K243213 — Self-Forming Magnet (FLEX SFM)
- K242086 — MagDI System (MAG-01, DS-01)
- DEN240013 — MagDI System
Data sourced from openFDA. This site is unofficial and independent of the FDA.