# K091832: Endogastric Solutions Stomaphyx System with Serosafuse Fastener

- Pathway: 510(k) (Special)
- Applicant: Endogastric Solutions, Inc.
- Decided: Jul 22, 2009 after 30 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K972679 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007) Summary page 1.
- K073644: Endogastric Solutions Stomaphyx  Device and Accessories, Endogastric Solutions, Inc. (2008) Summary page 1.

## Indications for use
The EndoGastric Solutions, StomaphyX System with SerosaFuse Fastener is intended for transoral tissue approximation, ligation and full-thickness plication in the G.I. tract.

Source page: https://510kreport.com/device/K091832
Methodology: https://510kreport.com/methodology