510(k) · Cleared
ClearedEsophyX® 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 May 1, 2016 as substantially equivalent to K143645 (Endogastric Solutions, Inc., 2015) after a 26-day review. Its family tree reaches back 8 generations to 1997. 3 later devices descend from it.
- Decided
- May 1, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K972679 (1997). 12 ancestors in all, the oldest K934738 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 7 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 6 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 5 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 4 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 3 generations backK092400 Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and…Endogastric Solutions, Inc. · 2009 · Recalled
- 2 generations backK142113 ESOPHYX2 HDEndogastric Solutions, Inc. · 2014
- 1 generation backK143645 EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc. · 2015
- This deviceK160960 EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171307 EsophyX2 HD Device with SerosaFuse Fasteners and Accessories…Endogastric Solutions, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK172811 EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK240879 EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2024 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…Endogastric Solutions, Inc. · 2017 · cites it directly2descendants
- K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc. · 2017 · 2 generations on1descendant
- K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −7 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −6 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −5 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −4 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −3 | K092400 | Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and… | Endogastric Solutions, Inc. | 2009 | 2 |
| −2 | K142113 | ESOPHYX2 HD | Endogastric Solutions, Inc. | 2014 | — |
| −1 | K143645 | EsophyX® Z Fastener Delivery Device | Endogastric Solutions, Inc. | 2015 | — |
| 0 (this device) | K160960 | EsophyX® Z Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2016 | — |
| +1 | K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device… | Endogastric Solutions, Inc. | 2017 | — |
| +2 | K172811 | EsophyX Z, EsophyX2 HD | Endogastric Solutions, Inc. | 2017 | — |
| +3 | K240879 | EsophyX Z+ Device with SerosaFuse Fasteners and Accessories | Endogastric Solutions, Inc. | 2024 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K143645 | EsophyX® Z Fastener Delivery DeviceSummary page 4…6.1500 Classification: Class II Predicate Device(s) [807.92(a)(3)]: The predicate device is the EndoGastric Solutions EsophyX Z System cleared via 510(k) # K143645. Device Description: [807.92(a)(4)]: The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a pr… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171307 | EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with… | 2017 | 2 |
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 19 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K171307 (Endogastric Solutions, Inc., 2017) has gone furthest, with 2 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. 2016, 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 gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160960 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160960: 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/K160960
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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