Device class
Class II
Regulation 878.4816
Total clearances
9
2024-07-02 → 2026-09-16
Definition
What is Magnetic Compression Anastomosis System
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 details
Medical specialty
General, Plastic Surgery
Regulation number
878.4816
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 43632 |
CPT
|
— |
Medium
|
CPT for laparoscopic gastroenterostomy, relevant to GI tract anastomosis procedures |
| 43633 |
CPT
|
— |
Medium
|
CPT for laparoscopic gastrojejunostomy, applicable to magnetic compression anastomosis creation |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-16 |
K261467 |
Gt Metabolic Solutions, Inc.
|
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) |
| 2026-06-04 |
K253102 |
Gt Metabolic Solutions, Inc.
|
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) |
| 2026-01-09 |
K253550 |
GI Windows, Inc.
|
Self-Forming Magnet (Flexagon Plus OTOLoc) |
| 2025-08-01 |
K250541 |
GI Windows, Inc.
|
Self-Forming Magnet (Flexagon Plus OTOLoc) |
| 2025-06-11 |
K243482 |
GI Windows, Inc.
|
Self-Forming Magnet (Flexagon) |
| 2025-02-28 |
K243359 |
Gt Metabolic Solutions, Inc.
|
MagDI System (MAG-02, DS-01) |
| 2025-01-29 |
K243213 |
GI Windows, Inc.
|
Self-Forming Magnet (FLEX SFM) |
| 2024-10-24 |
K242086 |
Gt Metabolic Solutions, Inc.
|
MagDI System (MAG-01, DS-01) |
| 2024-07-02 |
DEN240013 |
Gt Metabolic Solutions, Inc.
|
MagDI System |