# K092400: Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model 2.7.5

- Pathway: 510(k) (Special)
- Applicant: Endogastric Solutions, Inc.
- Decided: Nov 6, 2009 after 92 days
- Product code: ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- 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.
6 later devices descend from it; 1 cites it directly.
0 of 16 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.

## Most influential descendants
- 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
- K171307: EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories (2017), 2 descendants of its own
- K172811: EsophyX Z, EsophyX2 HD (2017), 1 descendant of its own

## Recalls of this device
- Jun 6, 2013 · Class II · Z-1982-2013: Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention w
- Feb 4, 2013 · Class II · Z-1136-2013: EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

## Indications for use
The EndoGastric Solutions EsophyX2 Device with SerosaFuse Fastener and Accessories is indicated for use in 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/K092400
Methodology: https://510kreport.com/methodology