510(k) · Cleared
ClearedEndogastric Solutions Stomaphyx Device and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endogastric Solutions, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Jun 27, 2008 as substantially equivalent to K071651 (Endogastric Solutions, Inc., 2007) and 1 other predicate after a 184-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 184 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K972679 (1997). 9 ancestors in all, the oldest K934738 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 4 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 3 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 2 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 1 generation backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- This deviceK073644 Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK101252 Neotract Anchor System Model: Ref 11208Neotract, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK102028 Neotract Anchor System Model TAS400Neotract, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK091832 Endogastric Solutions Stomaphyx System with Serosafuse FastenerEndogastric Solutions, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K101252Neotract Anchor System Model: Ref 11208Neotract, Inc. · 2010 · cites it directly1descendant
- K102028Neotract Anchor System Model TAS400Neotract, Inc. · 2010 · 2 generations on0descendants
- K091832Endogastric Solutions Stomaphyx System with Serosafuse FastenerEndogastric Solutions, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −4 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −3 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −2 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −1 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| 0 (this device) | K073644 | Endogastric Solutions Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2008 | — |
| +1 | K101252 | Neotract Anchor System Model: Ref 11208 | Neotract, Inc. | 2010 | — |
| +2 | K102028 | Neotract Anchor System Model TAS400 | Neotract, Inc. | 2010 | — |
| +1 | K091832 | Endogastric Solutions Stomaphyx System with Serosafuse Fastener | Endogastric Solutions, Inc. | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesSummary page 1…tions StomaphyX Device and Implantable Fasteners is substantially equivalent in intended use and method of operation to a combination of the following predicate devices: K07 1651 - EndoGastric Solutions EsophyX System with SerosaFuse Fastener and accessories K062875 - EndoGastric Solutions StomaphyX Device… | 2007 |
| * | K062875 | Endogastric Stomaphyx Device and AccessoriesSummary page 1…use and method of operation to a combination of the following predicate devices: K07 1651 - EndoGastric Solutions EsophyX System with SerosaFuse Fastener and accessories K062875 - EndoGastric Solutions StomaphyX Device and accessories EndoGastric Solutions, Inc. 5 10(k) Submission. June 23, 2008 === P… | 2007 |
What descends from it? (3)
2 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 11 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K101252 (Neotract, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071651.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The EndoGastric Solutions StomaphyX TM system with SerosaFuseTM Fastener is intended
for tissue approximation, ligation and full-thickness plication in the G.I. tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073644 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073644: Endogastric Solutions Stomaphyx Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073644
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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