# K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Endogastric Solutions, Inc.
- Decided: Sep 14, 2007 after 88 days
- Product code: ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
- 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: 4 generations back to K972679 (1997). 8 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023234: Endoscopic Plication System, Ndo Surgical, Inc. (2003) Summary page 1.
- K994290: Bard Endoscopic Suturing System, C.R. Bard, Inc. (2000) Summary page 1.
- K003956: Bard Endocinch Suturing System # 000452; 000454; 000595, C.R. Bard, Inc. (2001) Summary page 1.
- K062875: Endogastric Stomaphyx Device and Accessories, Endogastric Solutions, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K160960: EsophyX® Z Device with SerosaFuse Fasteners and Accessories (2016), 3 descendants of its own
- K120299: SRS Endoscopic Stapling System (2012), 3 descendants of its own

## Indications for use
The EndoGastric Solutions (EGS) EsophyX TM System with SerosaFuseiM Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the Gi tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia < 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Source page: https://510kreport.com/device/K071651
Methodology: https://510kreport.com/methodology