# K143645: EsophyX® Z Fastener Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Endogastric Solutions, Inc.
- Decided: Mar 4, 2015 after 72 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: 7 generations back to K972679 (1997). 11 ancestors in all.
4 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)
- K142113: ESOPHYX2 HD, Endogastric Solutions, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K240879: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (2024), 0 descendants of its own

## Indications for use
The EndoGastric Solutions EsophyX Z Fastener Delivery Device with SerosaFuse Fasteners 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/K143645
Methodology: https://510kreport.com/methodology