# K031262: Endoscopic Plication System, Model 160-00760

- Pathway: 510(k) (Special)
- Applicant: Ndo Surgical, Inc.
- Decided: May 23, 2003 after 32 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: 1 generation back to K023234 (2003). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 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 4.

## Most influential descendants
- K120299: SRS Endoscopic Stapling System (2012), 3 descendants of its own
- K132151: SRS Endoscopic Stapling System (2014), 2 descendants of its own
- K143634: MUSE System (2015), 1 descendant of its own
- K151001: MUSE System (2015), 0 descendants of its own

## Indications for use
The NDO EPS System is indicated for the treatment of the symptoms of chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.

Source page: https://510kreport.com/device/K031262
Methodology: https://510kreport.com/methodology