# K233240: GERDX-System

- Pathway: 510(k) (Traditional)
- Applicant: G-Surg GmbH
- Decided: Jun 21, 2024 after 267 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: 3 generations back to K023234 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071553: Endoscopic Plication System; Eps; Plicator, Ndo Surgical, Inc. (2007) Summary page 5.

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

Source page: https://510kreport.com/device/K233240
Methodology: https://510kreport.com/methodology