Magnetic Compression Anastomosis System
A magnetic compression anastomosis system is a surgical device used to create anastomoses in minimally invasive and laparoscopic gastrointestinal surgery by harnessing the polar attraction between magnet devices placed on tissue; compression and necrosis at the contact zone allow an anastomosis to form, after which the magnets are expelled naturally. It is classified as FDA Class II (510(k) required) under regulation 878.4816 in the General and Plastic Surgery specialty, with product code SAH. The device is not an implant, does not support life-sustaining functions, and does not include devices intended for weight loss or metabolic disease treatment.
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Basic Information
- Product Code
- SAH
- Device Class
- FDA class 2
- Regulation Number
- 878.4816
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Jun 04, 2026 | Substantially Equivalent | Gt Metabolic Solutions, Inc. |
| K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | Jan 09, 2026 | Substantially Equivalent | GI Windows, Inc. |
| K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | Aug 01, 2025 | Substantially Equivalent | GI Windows, Inc. |
| K243482 | Self-Forming Magnet (Flexagon) | Jun 11, 2025 | Substantially Equivalent | GI Windows, Inc. |
| K243359 | MagDI System (MAG-02, DS-01) | Feb 28, 2025 | Substantially Equivalent | Gt Metabolic Solutions, Inc. |
| K243213 | Self-Forming Magnet (FLEX SFM) | Jan 29, 2025 | Substantially Equivalent | GI Windows, Inc. |
| K242086 | MagDI System (MAG-01, DS-01) | Oct 24, 2024 | Substantially Equivalent | Gt Metabolic Solutions, Inc. |
| DEN240013 | MagDI System | Jul 02, 2024 | Unknown | Gt Metabolic Solutions, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.