510(k) · Cleared
ClearedModification to Seamguard Staple Line Reinforcement Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · OXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
Cleared on May 21, 2001 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- May 21, 2001
- Review
- 54 days
- Class
- Class II
- Product code
- OXD
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK010936 Modification to Seamguard Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK022044 Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK021477 Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK113071 Synthecel Dura Replacement DevicesSynthes · 2012 · Recalled
- Descendant · 3 generations on · 2 of its ownK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K022044Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002 · cites it directly6descendants
- K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005 · 2 generations on3descendants
- K021477Preclude MVP Dura SubstituteW. L. Gore & Associates, Inc. · 2002 · cites it directly3descendants
- K113071Synthecel Dura Replacement DevicesSynthes · 2012 · 2 generations on2descendants
- K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010936 | Modification to Seamguard Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2001 | — |
| +1 | K022044 | Surgisis Staple Line Reinforcement | Cook Biotech, Inc. | 2002 | — |
| +2 | K051048 | Surgisis Staple Line Reinforcement II | Cook Biotech, Inc. | 2005 | — |
| +1 | K021477 | Preclude MVP Dura Substitute | W. L. Gore & Associates, Inc. | 2002 | — |
| +2 | K113071 | Synthecel Dura Replacement Devices | Synthes | 2012 | 5 |
| +3 | K070405 | Modification to Surgisis SLR Staple Line Reinforcement | Cook Biotech, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OXD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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?
- Of its descendants, K022044 (Cook Biotech, Inc., 2002) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OXD devicesOXD Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXD
FDA has decided no OXD device since 2007.
Median 510(k) review, days · OXD
Too few OXD 510(k)s in any year since 2007 to give a median.
Recalls per year · OXD
No recall names OXD since 2007.
Adverse event reports per year · OXD
3in 2025
MAUDE reports naming product code OXD, 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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010936: Modification to Seamguard Staple Line Reinforcement Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010936
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026