510(k) · Cleared
ClearedGore Seamguard Reinforcement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Cleared on Sep 6, 2013 as substantially equivalent to K043056 (W. L. Gore & Associates, Inc., 2004) after a 92-day review. Its family tree reaches back 8 generations to 1985. 1 later device descends from it.
- Decided
- Sep 6, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- OXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K842066 (1985). 22 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 5 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 4 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 3 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK032865 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK043056 Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2004
- This deviceK131658 Gore Seamguard ReinforcementW. L. Gore & Associates, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK150551 GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −7 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −5 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −4 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −3 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K032865 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2004 | — |
| 0 (this device) | K131658 | Gore Seamguard Reinforcement | W. L. Gore & Associates, Inc. | 2013 | — |
| +1 | K150551 | GORE SEAMGUARD Reinforcement | W. L. Gore & Associates, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 OXC? 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 OXC device
- #1 K252906 ECHELON ENDOPATH Staple Line Reinforcement…score 13.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K043056 | Gore Seamguard Bioabsorbable Staple Line Reinforcement MaterialSummary page 1…Mesh, Surgical, absorbable, staple line reinforcement (21 CFR878.3300) Product Code: OXC Predicate Device K043056 GORE® SEAMGUARD® Bloabsorbable Staple Line Reinforcement Material Device Description The subject GORE@ SEAMGUA… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150551 | GORE SEAMGUARD Reinforcement | 2015 | 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 28 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K150551 (W. L. Gore & Associates, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K043056.
How does its category compare?
All OXC devicesOXC Mesh, Surgical, Absorbable, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OXC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OXC
Too few OXC 510(k)s in any year since 2007 to give a median.
Recalls per year · OXC
No recall names OXC since 2007.
Adverse event reports per year · OXC
45in 2025
MAUDE reports naming product code OXC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 33 |
| 2022 | 2 | — | 0 | 164 |
| 2023 | 1 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 38 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131658: Gore Seamguard Reinforcement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131658
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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