510(k) K250541
K250541 is an FDA 510(k) premarket notification submitted by GI Windows, Inc. for the device "Self-Forming Magnet (Flexagon Plus OTOLoc)". The FDA issued a decision of Substantially Equivalent on Aug 1, 2025. The device falls under product code SAH (Magnetic Compression Anastomosis System), a Class II device regulated under 21 CFR 878.4816. GI Windows, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 1, 2025
- Date Received
- Feb 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Magnetic Compression Anastomosis System
- Device Class
- Class II
- Regulation Number
- 878.4816
- Review Panel
- SU
- Submission Type
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