510(k) · Cleared
ClearedEndoscopic Plication System; Eps; Plicator
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 Sep 18, 2007 as substantially equivalent to K023234 (Ndo Surgical, Inc., 2003) and 1 other predicate after a 104-day review. Its family tree reaches back 2 generations to 2003. 10 later devices descend from it.
- Decided
- Sep 18, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K023234 (2003). 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK023234 Endoscopic Plication SystemNdo Surgical, Inc. · 2003
- 1 generation backK032820 Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 2003 · Recalled
- This deviceK071553 Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK072125 Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK120299 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK073671 Plicator GSX Suturing System, Plicator GSX, Plicator Instrument…Ndo Surgical, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK132151 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK082044 Ace Stapler, Model F0031Barosense, Inc. · 2010
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K072125Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 2007 · cites it directly4descendants
- K120299SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012 · cites it directly3descendants
- K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…Ndo Surgical, Inc. · 2008 · cites it directly3descendants
- K132151SRS Endoscopic Stapling SystemMedigus, Ltd. · 2014 · 2 generations on2descendants
- K082044Ace Stapler, Model F0031Barosense, Inc. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023234 | Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | — |
| −1 | K032820 | Modification to Endoscopic Plication System | Ndo Surgical, Inc. | 2003 | 1 |
| 0 (this device) | K071553 | Endoscopic Plication System; Eps; Plicator | Ndo Surgical, Inc. | 2007 | — |
| +1 | K072125 | Endoscopic Plication System, Eps, Eplicator, Plicator Instrument | Ndo Surgical, Inc. | 2007 | — |
| +1 | K120299 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2012 | — |
| +1 | K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX… | Ndo Surgical, Inc. | 2008 | — |
| +2 | K132151 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2014 | — |
| +2 | K082044 | Ace Stapler, Model F0031 | Barosense, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2024 | 1 | 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? (2)
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 1…Common Name: Endoscope accessory Classification Name: Endoscope and accessories Class: II 3. PREDICATE DEVICE: NDO Surgical Endoscopic Plication System (K023234, K032820) 4. DEVICE DESCRIPTION: The NDO Surgical Endoscopic Plication System (EPS) is a device that deploys a suture… | 2003 |
| * | K032820 | Modification to Endoscopic Plication SystemSummary page 1…me: Endoscope accessory Classification Name: Endoscope and accessories Class: II 3. PREDICATE DEVICE: NDO Surgical Endoscopic Plication System (K023234, K032820) 4. DEVICE DESCRIPTION: The NDO Surgical Endoscopic Plication System (EPS) is a device that deploys a suture-based im… | 2003 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K072125 (Ndo Surgical, Inc., 2007) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K023234.
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. 2007, 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 NDO EPS System (PlicatorTM) 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 as stated in the FDA summary.
https://510kreport.com/device/K071553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071553: Endoscopic Plication System; Eps; Plicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071553
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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