# K083266: Gore Bio-a Fistula Plug

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Mar 27, 2009 after 142 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K842066 (1985). 40 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 1.
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 1.

## Most influential descendants
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- 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

## Indications for use
The GORE Fistula Plug device is intended for use in the reinforcement of soft tissue for the repair of anorectal fistulas;

Source page: https://510kreport.com/device/K083266
Methodology: https://510kreport.com/methodology