# K240879: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories

- Pathway: 510(k) (Special)
- Applicant: Endogastric Solutions, Inc.
- Decided: Apr 26, 2024 after 28 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: 11 generations back to K972679 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172811: EsophyX Z, EsophyX2 HD, Endogastric Solutions, Inc. (2017) Summary page 5.

## Recalls of this device
- Mar 14, 2025 · Class II · Z-1641-2025: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Mar 14, 2025 · Class II · Z-1640-2025: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.

## Indications for use
The EndoGastric Solutions EsophyX Z+ 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 junction and reduce hiatal hernia 5 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

Source page: https://510kreport.com/device/K240879
Methodology: https://510kreport.com/methodology