510(k) · Cleared
ClearedBard Endocinch Suturing System # 000452; 000454; 000595
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Cleared on Jan 5, 2001 after a 15-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Jan 5, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 6 citing it directly.
- This deviceK003956 Bard Endocinch Suturing System # 000452; 000454; 000595C.R. Bard, Inc. · 2001
- Descendant · cites it directly · 21 of its ownK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- Descendant · cites it directly · 14 of its ownK061770 Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK081853 Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK171886 OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K062875Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007 · cites it directly21descendants
- K071651Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesEndogastric Solutions, Inc. · 2007 · cites it directly15descendants
- K061770Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc. · 2006 · cites it directly14descendants
- K081853Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc. · 2008 · cites it directly8descendants
- K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc. · 2017 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003956 | Bard Endocinch Suturing System # 000452; 000454; 000595 | C.R. Bard, Inc. | 2001 | — |
| +1 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| +1 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| +1 | K061770 | Ethicon Endo Surgery Endoscopic Suturing System | Ethicon Endo-Surgery, Inc. | 2006 | — |
| +1 | K081853 | Overstitch Endoscopic Suture System | Apollo Endosurgery, Inc. | 2008 | — |
| +2 | K171886 | OverStitch SX Endoscopic Suturing System (ESS) | Apollo Endosurgery, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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® Endoscopic Suturing System Named without a submission number | |
| * | — | Y-Knot Suture Clip Named without a submission number | |
| * | — | SutureLok Named without a submission number |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062875 | Endogastric Stomaphyx Device and Accessories | 2007 | 21 |
| K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and Accessories | 2007 | 15 |
| K061770 | Ethicon Endo Surgery Endoscopic Suturing System | 2006 | 14 |
| K081853 | Overstitch Endoscopic Suture System | 2008 | 8 |
| K070151 | Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier | 2007 | 4 |
| 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, K062875 (Endogastric Solutions, Inc., 2007) has gone furthest, with 21 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?
For endoscopic placement of suture(s) in the soft
tissue of the esophagus and stomach and for
approximation of tissue for the treatment of
symptomatic Gastroesophageal Reflux Disease.
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/K003956 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003956: Bard Endocinch Suturing System # 000452; 000454; 000595.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003956
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026