# K010228: Gore-Tex Dualmesh Plus Biomaterial with Holes

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Feb 21, 2001 after 28 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K072974: Surgimesh XB (2008), 3 descendants of its own
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (2010), 1 descendant of its own
- K120025: Surgimesh XB - Skirted (2012), 0 descendants of its own
- K112567: Biomerix Assure (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K010228
Methodology: https://510kreport.com/methodology