# K032820: Modification to Endoscopic Plication System

- Pathway: 510(k) (Special)
- Applicant: Ndo Surgical, Inc.
- Decided: Oct 23, 2003 after 43 days
- Product code: ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd))
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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.
11 later devices descend from it; 2 cite it directly.
0 of 13 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
- K071553: Endoscopic Plication System; Eps; Plicator (2007), 10 descendants of its own
- K072125: Endoscopic Plication System, Eps, Eplicator, Plicator Instrument (2007), 4 descendants of its own
- K120299: SRS Endoscopic Stapling System (2012), 3 descendants of its own
- K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge (2008), 3 descendants of its own
- K132151: SRS Endoscopic Stapling System (2014), 2 descendants of its own

## Recalls of this device
- Jan 26, 2007 · Not classified · Z-0685-2007: Device arm may fail to open after being deployed and require surgical intervention to remove

## 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/K032820
Methodology: https://510kreport.com/methodology