510(k) · Cleared
ClearedEndoscopic Plication System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndo Surgical, Inc. · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Cleared on Apr 17, 2003 after a 202-day review. The FDA summary names its predicate without a number. 25 later devices descend from it.
- Decided
- Apr 17, 2003
- Review
- 202 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 0
25 later devices descend from it, 6 citing it directly.
- This deviceK023234 Endoscopic Plication SystemNdo Surgical, Inc. · 2003
- Descendant · cites it directly · 15 of its ownK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- Descendant · cites it directly · 11 of its ownK032820 Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 2003 · Recalled
- Descendant · cites it directly · 10 of its ownK071553 Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007
- Descendant · 2 generations on · 6 of its ownK092400 Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and…Endogastric Solutions, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 5 of its ownK142113 ESOPHYX2 HDEndogastric Solutions, Inc. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K071651Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesEndogastric Solutions, Inc. · 2007 · cites it directly15descendants
- K032820Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 2003 · cites it directly11descendants
- K071553Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007 · cites it directly10descendants
- K092400Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…Endogastric Solutions, Inc. · 2009 · 2 generations on6descendants
- K142113ESOPHYX2 HDEndogastric Solutions, Inc. · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023234 | Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | — |
| +1 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| +1 | K032820 | Modification to Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | 1 |
| +1 | K071553 | Endoscopic Plication System; Eps; Plicator | Ndo Surgical, Inc. | 2007 | — |
| +2 | K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and… | Endogastric Solutions, Inc. | 2009 | 2 |
| +3 | K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2024 | 2 | 0 |
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
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | Bard EndoCinch Suturing System Named without a submission number |
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories | 2007 | 15 |
| K032820 | Modification to Endoscopic Plication System | 2003 | 11 |
| K071553 | Endoscopic Plication System; Eps; Plicator | 2007 | 10 |
| K031262 | Endoscopic Plication System, Model 160-00760 | 2003 | 4 |
| K120299 | SRS Endoscopic Stapling System | 2012 | 3 |
| K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture… | 2008 | 3 |
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?
- Of its descendants, K071651 (Endogastric Solutions, Inc., 2007) has gone furthest, with 15 descendants of its own.
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.
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 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K023234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023234: Endoscopic Plication System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023234
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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