# K992189: Gore-Tex Dualmesh Biomaterial

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Jul 29, 1999 after 30 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
No predicates in its family tree.
41 later devices descend from it; 5 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GORE-TEX® DualMesh® Biomaterial with a “hexagon” identification pattern: named in the summary without a submission number

## Most influential descendants
- K081069: Gore Infinit Mesh (2008), 21 descendants of its own
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own
- K081777: Ventrio Hernia Patch (2008), 14 descendants of its own
- K100229: Ventrio Hernia Patch (2010), 13 descendants of its own
- K073391: Surgisis Biodesign Tissue Graft (2008), 8 descendants of its own

## Indications for use
GORE-TEX DualMesh Biomaterial is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Source page: https://510kreport.com/device/K992189
Methodology: https://510kreport.com/methodology