510(k) · Cleared
ClearedGore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh Biomaterial with Holes
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 Oct 25, 1996 as substantially equivalent to K830889 (Davis & Geck, Inc., 1983) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Oct 25, 1996
- Review
- 45 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K810428 (1981). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK810428 VicrylETHICON, Inc. · 1981
- This deviceK963619 Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh…W. L. Gore & Associates, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810428 | Vicryl | ETHICON, Inc. | 1981 | — |
| 0 (this device) | K963619 | Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh… | W. L. Gore & Associates, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 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? (6)
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 |
|---|---|---|---|
| * | K830889 | Dexon 'S' Polyglycolic Acid MeshSummary page 1…e devices: GORE-TEX" Soft Tissue Patch GORE-TEX® MycroMesh Biomaterial GORE-TEX® DualMegh Biomaterial GORE-TEX® DualMesh Biomaterial with Holes Davis & Geck DEXON Mesh K 830889 Ethicon Vicryl Woven Mesh K 810428 4. Device Description: The applicant GORE surgical meshes are not being changed in any way… | 1983 |
| * | K810428 | VicrylSummary page 1…tch GORE-TEX® MycroMesh Biomaterial GORE-TEX® DualMegh Biomaterial GORE-TEX® DualMesh Biomaterial with Holes Davis & Geck DEXON Mesh K 830889 Ethicon Vicryl Woven Mesh K 810428 4. Device Description: The applicant GORE surgical meshes are not being changed in any way (except for labeling) as a result of… | 1981 |
| * | — | GORE-TEX® Soft Tissue Patch Named without a submission number | |
| * | — | GORE-TEX® MycroMesh Biomaterial Named without a submission number | |
| * | — | GORE-TEX® DualMesh Biomaterial Named without a submission number | |
| * | — | GORE-TEX® DualMesh Biomaterial with Holes Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K830889.
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 applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.
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/K963619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963619: Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh Biomaterial with Holes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963619
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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