# K071553: Endoscopic Plication System; Eps; Plicator

- Pathway: 510(k) (Traditional)
- Applicant: Ndo Surgical, Inc.
- Decided: Sep 18, 2007 after 104 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: 2 generations back to K023234 (2003). 2 ancestors in all.
10 later devices descend from it; 4 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 1.
- K032820: Modification to Endoscopic Plication System, Ndo Surgical, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K082044: Ace Stapler, Model F0031 (2010), 2 descendants of its own

## Indications for use
The NDO EPS System (PlicatorTM) 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/K071553
Methodology: https://510kreport.com/methodology
