# K063435: Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 28, 2006 after 15 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: 1 generation back to K946106 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946106: Gore-Tex Dualmesh Plus Biomaterial, W. L. Gore & Associates, Inc. (1995) Summary page 1.

## Indications for use
Reconstruction of Hernias and Soft Tissue Deficiencies and for the Temporary Bridging of Fascial Defects

Source page: https://510kreport.com/device/K063435
Methodology: https://510kreport.com/methodology