# K023234: Endoscopic Plication System

- Pathway: 510(k) (Traditional)
- Applicant: Ndo Surgical, Inc.
- Decided: Apr 17, 2003 after 202 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
No predicates in its family tree.
25 later devices descend from it; 6 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard EndoCinch Suturing System: named in the summary without a submission number

## Most influential descendants
- K071651: Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories (2007), 15 descendants of its own
- K032820: Modification to Endoscopic Plication System (2003), 11 descendants of its own
- K071553: Endoscopic Plication System; Eps; Plicator (2007), 10 descendants of its own
- K092400: Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model 2.7.5 (2009), 6 descendants of its own
- K142113: ESOPHYX2 HD (2014), 5 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 phammacological therapy.

Source page: https://510kreport.com/device/K023234
Methodology: https://510kreport.com/methodology