# K132397: Gore Bio-a Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 7, 2014 after 279 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842066 (1985). 75 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 5.
- K022127: Avagen Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 5.
- K090160: Suprathel Wound and Burn Dressing, Polymedics Innovations, GmbH (2009) Summary page 5.
- K083266: Gore Bio-a Fistula Plug, W. L. Gore & Associates, Inc. (2009) Summary page 5.

## Most influential descendants
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (2016), 3 descendants of its own
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own
- K232847: SiOxD Wound Matrix (2023), 1 descendant of its own
- K193583: Restrata® (2020), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K132397
Methodology: https://510kreport.com/methodology