# K243482: Self-Forming Magnet (Flexagon)

- Pathway: 510(k) (Traditional)
- Applicant: GI Windows, Inc.
- Decided: Jun 11, 2025 after 215 days
- Product code: SAH (Magnetic Compression Anastomosis System)
- Device class: 2
- Regulation: 21 CFR 878.4816
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN240013 (2024). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243213: Self-Forming Magnet (FLEX SFM), GI Windows, Inc. (2025). Cleared while this submission was under review Summary page 8.

## Most influential descendants
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc) (2025), 1 descendant of its own
- K253550: Self-Forming Magnet (Flexagon Plus OTOLoc) (2026), 0 descendants of its own

## Indications for use
The GI Windows FLEXAGON System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows FLEXAGON is intended for use in adult patients > 21 years.

Source page: https://510kreport.com/device/K243482
Methodology: https://510kreport.com/methodology