510(k) · Cleared
ClearedGERDX-System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G-Surg GmbH · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Cleared on Jun 21, 2024 as substantially equivalent to K071553 (Ndo Surgical, Inc., 2007) after a 267-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jun 21, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K023234 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK023234 Endoscopic Plication SystemNdo Surgical, Inc. · 2003
- 2 generations backK032820 Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 2003 · Recalled
- 1 generation backK071553 Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007
- This deviceK233240 GERDX-SystemG-Surg GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K023234 | Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | — |
| −2 | K032820 | Modification to Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | 1 |
| −1 | K071553 | Endoscopic Plication System; Eps; Plicator | Ndo Surgical, Inc. | 2007 | — |
| 0 (this device) | K233240 | GERDX-System | G-Surg GmbH | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODE device
- #1 K240879 EsophyX Z+ Device with SerosaFuse Fasteners…score 8.2 · 11 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071553 | Endoscopic Plication System; Eps; PlicatorSummary page 5…hageal Reflux Disease (Gerd), Class: II Regulation Number: 876.1500 Product Code: ODE 3. LEGALLY MARKETED PREDICATE DEVICES Endoscopic Plication System; Plicator™ (K071553); Product Code: ODE 4. DEVICE DESCRIPTION SUMMARY 510(k)_Summary_GERDX System_510(k)_20240617… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 3 other devices also cite its predicate K071553.
How does its category compare?
All ODE devicesODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · ODE
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ODE
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODE
No recall names ODE since 2007.
Adverse event reports per year · ODE
39in 2025
MAUDE reports naming product code ODE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 88 | 0 | 2 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 25 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 1 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 51 | 0 | 5 |
| 2016 | 1 | — | 0 | 12 |
| 2017 | 2 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 2 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233240: GERDX-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233240
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026