# K062875: Endogastric Stomaphyx Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Endogastric Solutions, Inc.
- Decided: Mar 9, 2007 after 164 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: 3 generations back to K972679 (1997). 6 ancestors in all.
21 later devices descend from it; 6 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011016: Lsi Solutions Flexible Suture Placement Device and Accessories Product, Lsi Solutions (2001) Summary page 4.
- K994290: Bard Endoscopic Suturing System, C.R. Bard, Inc. (2000) Summary page 4.
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 4.

## Most influential descendants
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), 15 descendants of its own
- K092400: Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model 2.7.5 (2009), 6 descendants of its own
- K142113: ESOPHYX2 HD (2014), 5 descendants of its own
- K143645: EsophyX® Z Fastener Delivery Device (2015), 4 descendants of its own
- K070151: Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier (2007), 4 descendants of its own

## Indications for use
The EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract.

Source page: https://510kreport.com/device/K062875
Methodology: https://510kreport.com/methodology