510(k) · Cleared
ClearedGore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial
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 Nov 28, 2006 as substantially equivalent to K946106 (W. L. Gore & Associates, Inc., 1995) after a 15-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Nov 28, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946106 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK946106 Gore-Tex Dualmesh Plus BiomaterialW. L. Gore & Associates, Inc. · 1995
- This deviceK063435 Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus BiomaterialW. L. Gore & Associates, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946106 | Gore-Tex Dualmesh Plus Biomaterial | W. L. Gore & Associates, Inc. | 1995 | — |
| 0 (this device) | K063435 | Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial | W. L. Gore & Associates, Inc. | 2006 | — |
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? (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 |
|---|---|---|---|
| * | K946106 | Gore-Tex Dualmesh Plus BiomaterialSummary page 1…n or Usual Name: Polymeric Surgical Mesh Classification 21 CFR 878.3300, FTL: General and Plastic Surgery Devices Device Predicate: GORE DUALMESH" PLUS BIOMATERIAL (K946106) Device Description: The GORE DUALMESHF PLUS and GORE MYCROMESH® PLUS Biomaterials are patch materials composed solely of expan… | 1995 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K946106.
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?
Reconstruction of Hernias and Soft Tissue Deficiencies and for the Temporary Bridging of Fascial Defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063435: Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063435
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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