510(k) · Cleared
ClearedVicryl
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 13, 1981 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 119 later devices descend from it.
- Decided
- Mar 13, 1981
- Review
- 23 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
119 later devices descend from it, 10 citing it directly.
- This deviceK810428 VicrylETHICON, Inc. · 1981
- Descendant · cites it directly · 39 of its ownK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
- Descendant · cites it directly · 17 of its ownK073287 Prevadh MeshSofradim Production · 2008
- Descendant · cites it directly · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K033671Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003 · cites it directly39descendants
- K040868Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004 · cites it directly34descendants
- K073287Prevadh MeshSofradim Production · 2008 · cites it directly17descendants
- K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · cites it directly17descendants
- K053066Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810428 | Vicryl | ETHICON, Inc. | 1981 | — |
| +1 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| +1 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | — |
| +1 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| +1 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| +1 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 9 | 0 |
| 2026 | 6 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (119)
See all 11910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033671 | Gore Bioabsorbable Mesh | 2003 | 39 |
| K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | 2004 | 34 |
| K073287 | Prevadh Mesh | 2008 | 17 |
| K070894 | Tephaflex Surgical Mesh | 2007 | 17 |
| K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | 2005 | 17 |
| K080442 | Seriscaffold Surgical Mesh | 2008 | 14 |
| K083307 | Synthasome X-Repair | 2009 | 9 |
| K123128 | Seri Surgical Scaffold | 2013 | 5 |
| K191373 | VICRYL Mesh | 2019 | 1 |
| K963619 | Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh… | 1996 | 0 |
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, K033671 (W. L. Gore & Associates, Inc., 2003) has gone furthest, with 39 descendants 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 | — |
https://510kreport.com/device/K810428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810428: Vicryl.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810428
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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