# K253550: Self-Forming Magnet (Flexagon Plus OTOLoc)

- Pathway: 510(k) (Traditional)
- Applicant: GI Windows, Inc.
- Decided: Jan 9, 2026 after 56 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: 12 generations back to K933887 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc), GI Windows, Inc. (2025) Summary page 5.

## Indications for use
The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of a side-to-side jejunum-jejunum and ileum-ileum 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 Plus OTOLoc System is intended for use in adult patients > 21 years.

Source page: https://510kreport.com/device/K253550
Methodology: https://510kreport.com/methodology