510(k) · Cleared
ClearedEndoscopic Plication System, Model 160-00760
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 May 23, 2003 as substantially equivalent to K023234 (Ndo Surgical, Inc., 2003) after a 32-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- May 23, 2003
- Review
- 32 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023234 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK023234 Endoscopic Plication SystemNdo Surgical, Inc. · 2003
- This deviceK031262 Endoscopic Plication System, Model 160-00760Ndo Surgical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK120299 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK132151 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2014
- Descendant · 3 generations on · 1 of its ownK143634 MUSE SystemMedigus, Ltd. · 2015
- Descendant · 4 generations on · 0 of its ownK151001 MUSE SystemMedigus, Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K120299SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012 · cites it directly3descendants
- K132151SRS Endoscopic Stapling SystemMedigus, Ltd. · 2014 · 2 generations on2descendants
- K143634MUSE SystemMedigus, Ltd. · 2015 · 3 generations on1descendant
- K151001MUSE SystemMedigus, Ltd. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023234 | Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | — |
| 0 (this device) | K031262 | Endoscopic Plication System, Model 160-00760 | Ndo Surgical, Inc. | 2003 | — |
| +1 | K120299 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2012 | — |
| +2 | K132151 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2014 | — |
| +3 | K143634 | MUSE System | Medigus, Ltd. | 2015 | — |
| +4 | K151001 | MUSE System | Medigus, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K023234 | Endoscopic Plication SystemSummary page 4…e Name: NDO Surgical Endoscopic Plication System Class: II Classification Name: Endoscope and accessories 3. PREDICATE DEVICE: NDO Surgical Endoscopic Plication System (K023234) 4. DEVICE DESCRIPTION: The NDO Surgical Endoscopic Plication System is a device intended to deliver an implant in the stomach n… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120299 | SRS Endoscopic Stapling System | 2012 | 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?
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 pharmacological 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/K031262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031262: Endoscopic Plication System, Model 160-00760.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031262
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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