510(k) · Cleared
ClearedGore Bio-a Fistula Plug
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 Mar 27, 2009 as substantially equivalent to K033671 (W. L. Gore & Associates, Inc., 2003) and 1 other predicate after a 142-day review. Its family tree reaches back 7 generations to 1985. 12 later devices descend from it.
- Decided
- Mar 27, 2009
- Review
- 142 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K842066 (1985). 40 ancestors in all, the oldest K810428 (1981). 12 later devices descend from it, 2 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 deviceK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
- Descendant · 3 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · 4 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · cites it directly10descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 2 generations on4descendants
- K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC · 2016 · 2 generations on3descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 3 generations on2descendants
- K232847SiOxD Wound MatrixSioxmed, LLC · 2023 · 4 generations on1descendant
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) | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | — |
| +1 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +2 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
| +2 | K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”… | Engineered Tissue Solutions, LLC | 2016 | — |
| +3 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +4 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
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 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K033671 | Gore Bioabsorbable MeshSummary page 1…mon Name: Fistuila Plug Classification: 21CFR878.3300 Classification Name: Surgical Mesh FDA product code: FTL Device Class: II Device Predicates:. 1. 510(k)#: K033671 Predicate Device name: Gore Bioabsorbable Mesh Manufacturer: W. L. Gore & Associates, Inc. 2. 510(k) #: K05033… | 2003 |
| * | K050337 | Sis Fistula PlugSummary page 1…Device Predicates:. 1. 510(k)#: K033671 Predicate Device name: Gore Bioabsorbable Mesh Manufacturer: W. L. Gore & Associates, Inc. 2. 510(k) #: K050337 Predicate Device Name: SIS Fistula Plug Manufacturer: Cook Biotech Incorporated Device Description: The GORE BIO-… | 2005 |
What descends from it? (12)
See all 122 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 24 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 40 ancestors have a recall of any class.
- Of its descendants, K132397 (W. L. Gore & Associates, Inc., 2014) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K033671.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The GORE Fistula Plug device is intended for use in the reinforcement of soft tissue for the repair of anorectal fistulas;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083266: Gore Bio-a Fistula Plug.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083266
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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