# K073644: Endogastric Solutions Stomaphyx  Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Endogastric Solutions, Inc.
- Decided: Jun 27, 2008 after 184 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: 5 generations back to K972679 (1997). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories, Endogastric Solutions, Inc. (2007) Summary page 1.
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007) Summary page 1.

## Most influential descendants
- K101252: Neotract Anchor System Model: Ref 11208 (2010), 1 descendant of its own
- K102028: Neotract Anchor System Model TAS400 (2010), 0 descendants of its own
- K091832: Endogastric Solutions Stomaphyx System with Serosafuse Fastener (2009), 0 descendants of its own

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

Source page: https://510kreport.com/device/K073644
Methodology: https://510kreport.com/methodology