510(k) · Cleared
ClearedEndogastric Solutions Stomaphyx System with Serosafuse Fastener
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 Jul 22, 2009 as substantially equivalent to K062875 (Endogastric Solutions, Inc., 2007) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jul 22, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K972679 (1997). 10 ancestors in all, the oldest K934738 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 5 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 4 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 3 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 2 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 1 generation backK073644 Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2008
- This deviceK091832 Endogastric Solutions Stomaphyx System with Serosafuse FastenerEndogastric Solutions, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −5 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −4 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −3 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −2 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −1 | K073644 | Endogastric Solutions Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2008 | — |
| 0 (this device) | 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 |
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 12.1 · 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 |
|---|---|---|---|
| * | K062875 | Endogastric Stomaphyx Device and AccessoriesSummary page 1…utions StomaphyX Device and Implantable Fasteners is substantially equivalent in intended use and method of operation to a combination of the following predicate device: K062875 - EndoGastric Solutions StomaphyX Device and Accessories K073644 - EndoGastric Solutions StomaphyX Device and Accessories Devic… | 2007 |
| * | K073644 | Endogastric Solutions Stomaphyx Device and AccessoriesSummary page 1…y equivalent in intended use and method of operation to a combination of the following predicate device: K062875 - EndoGastric Solutions StomaphyX Device and Accessories K073644 - EndoGastric Solutions StomaphyX Device and Accessories Device Description: The EndoGastric Solutions StomaphyX Delivery Syst… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 5 other devices also cite its predicate K062875.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 System with SerosaFuse Fastener is intended for transoral 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/K091832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091832: Endogastric Solutions Stomaphyx System with Serosafuse Fastener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091832
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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