510(k) · Cleared
ClearedBard Endoscopic Suturing System
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 Mar 20, 2000 as substantially equivalent to K934738 (United States Surgical, A Division of Tyco Healthc, 1994) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1997. 23 later devices descend from it.
- Decided
- Mar 20, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972679 (1997). 3 ancestors in all, the oldest K934738 (1994). 23 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 1 generation backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- This deviceK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 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 · 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
- Descendant · 4 generations on · 4 of its ownK143645 EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc. · 2015
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · 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
- 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
- K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc. · 2015 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −1 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| 0 (this device) | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| +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 | — |
| +2 | K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and… | Endogastric Solutions, Inc. | 2009 | 2 |
| +3 | K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014 | — |
| +4 | K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 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 | 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 |
|---|---|---|---|
| * | K934738 | Autosuture Endoscopic Suturing DeviceSummary page 4…) 262-4878 December 6, 1999 Bard® Endoscopic Suturing System Endoscopic Suture Device 78KOG — Endoscopic Suture Device ENDOPATH® Endoscopic 510(k)# Suturing Device #K934738 Suturing System #K 980022 The Bard® Endoscopic Suturing System consists of a capsule assembly with suction tubing and a fixed he… | 1994 |
| * | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs)Summary page 4…999 Bard® Endoscopic Suturing System Endoscopic Suture Device 78KOG — Endoscopic Suture Device ENDOPATH® Endoscopic 510(k)# Suturing Device #K934738 Suturing System #K 980022 The Bard® Endoscopic Suturing System consists of a capsule assembly with suction tubing and a fixed head knotpusher that attache… | 1998 |
What descends from it? (23)
See all 234 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 |
| K073671 | Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture… | 2008 | 3 |
| K003102 | Pare Endoscopic Suturing System | 2001 | 0 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K062875 (Endogastric Solutions, Inc., 2007) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K934738.
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/K994290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994290: Bard Endoscopic Suturing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994290
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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