510(k) · Cleared
ClearedGORE SYNECOR 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 Dec 11, 2015 as substantially equivalent to K093932 (Ethicon GmbH, 2010) and 2 other predicates after an 88-day review. Its family tree reaches back 7 generations to 1985. 3 later devices descend from it.
- Decided
- Dec 11, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K842066 (1985). 47 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 6 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 4 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 3 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 2 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 1 generation backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- This deviceK152609 GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK163576 GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · cites it directly1descendant
- K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · cites it directly0descendants
- K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −6 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −4 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −3 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −2 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| 0 (this device) | K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2015 | — |
| +1 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
| +1 | K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022 | — |
| +1 | K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K093932 | Ethicon Physiomesh, Flexible Composite MeshSummary page 4…ssification Device Name: GORE® SYNECOR Biomaterial Classification Name: Mesh, surgical, polymeric Classification; 21CFR878.3300 Product Code: FTL Predicate Devices o K093932 ETHICON PHYSIOMESH® Flexible Composite Mesh o K081069 GORE® INFINIT® Mesh e K033671 GORE® BIO-A® Tissue Reinforcement Device Des… | 2010 |
| * | K081069 | Gore Infinit MeshSummary page 4…assification Name: Mesh, surgical, polymeric Classification; 21CFR878.3300 Product Code: FTL Predicate Devices o K093932 ETHICON PHYSIOMESH® Flexible Composite Mesh o K081069 GORE® INFINIT® Mesh e K033671 GORE® BIO-A® Tissue Reinforcement Device Description GORE® SYNECOR Biomaterial is a composite mes… | 2008 |
| * | K033671 | Gore Bioabsorbable MeshSummary page 4…cal, polymeric Classification; 21CFR878.3300 Product Code: FTL Predicate Devices o K093932 ETHICON PHYSIOMESH® Flexible Composite Mesh o K081069 GORE® INFINIT® Mesh e K033671 GORE® BIO-A® Tissue Reinforcement Device Description GORE® SYNECOR Biomaterial is a composite mesh intended for use in the repa… | 2003 |
What descends from it? (3)
3 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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 5 of the 47 ancestors have a recall of any class.
- Of its descendants, K173333 (W. L. Gore & Associates, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093932.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
GORE® SYNECOR Biomaterial is intended for use in the repair of hernias and
abdominal wall or thoracic wall soft tissue deficiencies that may require the addition
of non-absorbable reinforcing or bridging material.
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/K152609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152609: GORE SYNECOR Biomaterial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152609
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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