510(k) · Cleared
Recalled · Class II · 2025EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endogastric Solutions, Inc. · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Cleared on Apr 26, 2024 as substantially equivalent to K172811 (Endogastric Solutions, Inc., 2017) after a 28-day review. Its family tree reaches back 11 generations to 1997. It has been recalled 2 times.
- Decided
- Apr 26, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- ODE
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 11 generations to K972679 (1997). 15 ancestors in all, the oldest K934738 (1994). No later device cites it as a predicate yet.
- Root · 11 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 7 generations between
- 3 generations backK160960 EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2016
- 2 generations backK171307 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories…Endogastric Solutions, Inc. · 2017
- 1 generation backK172811 EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. · 2017
- This deviceK240879 EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 10 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 9 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 8 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 7 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 6 generations backK092400 Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and…Endogastric Solutions, Inc. · 2009 · Recalled
- 5 generations backK142113 ESOPHYX2 HDEndogastric Solutions, Inc. · 2014
- 4 generations backK143645 EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc. · 2015
- 3 generations backK160960 EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2016
- 2 generations backK171307 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories…Endogastric Solutions, Inc. · 2017
- 1 generation backK172811 EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. · 2017
- This deviceK240879 EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −10 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −9 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −8 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −7 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −6 | K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and… | Endogastric Solutions, Inc. | 2009 | 2 |
| −5 | K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014 | — |
| −4 | K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015 | — |
| −3 | K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2016 | — |
| −2 | K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device… | Endogastric Solutions, Inc. | 2017 | — |
| −1 | K172811 | EsophyX Z, EsophyX2 HD | Endogastric Solutions, Inc. | 2017 | — |
| 0 (this device) | K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 K233240 GERDX-Systemscore 8.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K172811 | EsophyX Z, EsophyX2 HDSummary page 5…eflux Disease (Gerd) Regulatory Class: II Product Code: ODE Predicate Device: EndoGastric Solutions, Inc., EsophyX Z Device with SerosaFuse Fasteners and Accessories (K172811) Device Description The EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is a prescription use only, d… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 14, 2025 | Class II | Z-1641-2025 | Under Investigation by firm | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| Mar 14, 2025 | Class II | Z-1640-2025 | Under Investigation by firm | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 15 ancestors have a recall of any class.
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. 2024, 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 EndoGastric Solutions EsophyX Z+ Device with SerosaFuse Fasteners and Accessories is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the junction and reduce hiatal hernia 5 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240879: EsophyX Z+ Device with SerosaFuse Fasteners and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240879
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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