510(k) · Cleared
ClearedGore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus Biomaterial/Dualmesh Plus Biomaterial with Hole
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Feb 6, 1997 after a 51-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Feb 6, 1997
- Review
- 51 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK965038 Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh…W. L. Gore & Associates, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK981051 Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus…W. L. Gore & Associates, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK032168 Gore-Tex Dualmesh Emerge Plus BiomaterialW. L. Gore & Associates, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K965038 | Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus… | W. L. Gore & Associates, Inc. | 1997 | — |
| +1 | K981051 | Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes | W. L. Gore & Associates, Inc. | 1998 | — |
| +1 | K032168 | Gore-Tex Dualmesh Emerge Plus Biomaterial | W. L. Gore & Associates, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | — | GORE-TEX® Soft Tissue Patch PLUS Named without a submission number | |
| * | — | GORE-TEX® DualMesh PLUS Biomaterial Named without a submission number | |
| * | — | GORE-TEX® MycroMesh PLUS Biomaterial Named without a submission number | |
| * | — | GORE-TEX® DualMesh PLUS Biomaterial with Holes Named without a submission number | |
| * | — | GORE-TEX® Soft Tissue Patch Named without a submission number | |
| * | — | GORE-TEX® DualMesh Biomaterial Named without a submission number | |
| * | — | GORE-TEX® MycroMesh Biomaterial Named without a submission number | |
| * | — | GORE-TEX® DualMesh Biomaterial with Holes Named without a submission number |
What descends from it? (2)
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?
- Of its descendants, K981051 (W. L. Gore & Associates, Inc., 1998) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The devices are indicated for use in the reconstruction of hernias and softs/tissue deficiencies and for the temporary bridging of fascial defects.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K965038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965038: Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus Biomaterial/Dualmesh Plus Biomaterial with Hole.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965038
Report an extraction error
Are you the manufacturer?
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