510(k) · Cleared
ClearedGore Bio-a Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · QSZ Absorbable Synthetic Wound Dressing
Cleared on May 7, 2014 as substantially equivalent to K021792 (Integra Lifesciences Corp., 2002) and 3 other predicates after a 279-day review. Its family tree reaches back 8 generations to 1985. 10 later devices descend from it.
- Decided
- May 7, 2014
- Review
- 279 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K842066 (1985). 75 ancestors in all, the oldest K810428 (1981). 10 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 7 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 5 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 4 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 3 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 2 generations backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- 1 generation backK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- This deviceK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
- Descendant · cites it directly · 3 of its ownK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
- Descendant · 2 generations on · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · 3 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK193583 Restrata®Acera Surgical, Inc. · 2020 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · cites it directly4descendants
- K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC · 2016 · cites it directly3descendants
- K222189SiOxD Wound MatrixSioxmed, LLC · 2022 · 2 generations on2descendants
- K232847SiOxD Wound MatrixSioxmed, LLC · 2023 · 3 generations on1descendant
- K193583Restrata®Acera Surgical, Inc. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −7 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −5 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −4 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −3 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| −1 | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | — |
| 0 (this device) | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +1 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
| +1 | K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”… | Engineered Tissue Solutions, LLC | 2016 | — |
| +2 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +3 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +2 | K193583 | Restrata® | Acera Surgical, Inc. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 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 QSZ? 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 QSZ device
- #1 K254256 LUOFUCON® Wound Matrixscore 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K021792 | Bilayer Matrix Wound DressingSummary page 5…Product Code: FRO (Dressing, wound, drug) Predicate Device The predicate devices to which the GORE® RIO-A® Wound Matrix is being compared are: * K021792 INTEGRA Tm Bilayer Matrix Wound Dressing (FRO) * K022127 AVAGEN Wound Dressing (KGN) * K090160 SUPRATHEL®Wound & Bu… | 2002 |
| * | K022127 | Avagen Wound DressingSummary page 5…cate Device The predicate devices to which the GORE® RIO-A® Wound Matrix is being compared are: * K021792 INTEGRA Tm Bilayer Matrix Wound Dressing (FRO) * K022127 AVAGEN Wound Dressing (KGN) * K090160 SUPRATHEL®Wound & Burn Dressing (FRO) * K083266 GORE® BIO-A® Fistula Plug (FT… | 2002 |
| * | K090160 | Suprathel Wound and Burn DressingSummary page 5…he GORE® RIO-A® Wound Matrix is being compared are: * K021792 INTEGRA Tm Bilayer Matrix Wound Dressing (FRO) * K022127 AVAGEN Wound Dressing (KGN) * K090160 SUPRATHEL®Wound & Burn Dressing (FRO) * K083266 GORE® BIO-A® Fistula Plug (FTL) GORE AND DES IGNS A… | 2009 |
| * | K083266 | Gore Bio-a Fistula PlugSummary page 5…* K021792 INTEGRA Tm Bilayer Matrix Wound Dressing (FRO) * K022127 AVAGEN Wound Dressing (KGN) * K090160 SUPRATHEL®Wound & Burn Dressing (FRO) * K083266 GORE® BIO-A® Fistula Plug (FTL) GORE AND DES IGNS ARE TRADEMARKS OF W. L. GORE & ASSOCIATES, INC. Integra… | 2009 |
What descends from it? (10)
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 29 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 75 ancestors have a recall of any class.
- Of its descendants, K170300 (Acera Surgical, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 8 other devices also cite its predicate K021792.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · QSZ
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QSZ
85in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSZ
No recall names QSZ since 2007.
Adverse event reports per year · QSZ
38in 2025
MAUDE reports naming product code QSZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 85 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 38 |
| 2026 | 4 | 159 | 0 | — |
What is it indicated for?
The GORE® BIO-A® Wound Matrix is intended for use in the management of wounds.
Wound types include: Partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, skin tears) and draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132397: Gore Bio-a Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132397
Report an extraction error
Are you the manufacturer?
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