# K946106: Gore-Tex Dualmesh Plus Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 24, 1995 after 131 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063435: Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial (2006), 0 descendants of its own
- K032168: Gore-Tex Dualmesh Emerge Plus Biomaterial (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K946106
Methodology: https://510kreport.com/methodology