# K032168: Gore-Tex Dualmesh Emerge Plus Biomaterial

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Aug 15, 2003 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
Longest line of descent: 2 generations back to K965038 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022782: Dualmesh Emerge & Emerge Plus Biomaterial, W. L. Gore & Associates, Inc. (2002) Summary page 2.
- K000185: Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM), W. L. Gore & Associates, Inc. (2000)
- K981051: Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes, W. L. Gore & Associates, Inc. (1998) Summary page 2.
- K965038: Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus Biomaterial/Dualmesh Plus Biomaterial with Hole, W. L. Gore & Associates, Inc. (1997) Summary page 2.
- K946106: Gore-Tex Dualmesh Plus Biomaterial, W. L. Gore & Associates, Inc. (1995) Summary page 2.

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

Source page: https://510kreport.com/device/K032168
Methodology: https://510kreport.com/methodology