# K022782: Dualmesh Emerge & Emerge Plus Biomaterial

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Sep 10, 2002 after 19 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.
24 later devices descend from it; 3 cite it directly.
0 of 25 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: named in the summary without a submission number
- (no number) GORE-TEX DualMesh PLUS Biomaterial: named in the summary without a submission number

## Most influential descendants
- K081777: Ventrio Hernia Patch (2008), 14 descendants of its own
- K100229: Ventrio Hernia Patch (2010), 13 descendants of its own
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), 7 descendants of its own
- K102766: Composix L/P Mesh with Echo PS Positioning System (2010), 6 descendants of its own
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own

## Indications for use
For the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects.

Source page: https://510kreport.com/device/K022782
Methodology: https://510kreport.com/methodology