# K965038: Gore-Tex Soft Tissue Patch Plus/Dualmesh Plus Biomaterial/Mycromesh Plus Biomaterial/Dualmesh Plus Biomaterial with Hole

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Feb 6, 1997 after 51 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. The FDA summary names its predicate without a number.
- (no number) GORE-TEX® Soft Tissue Patch PLUS: named in the summary without a submission number
- (no number) GORE-TEX® DualMesh PLUS Biomaterial: named in the summary without a submission number
- (no number) GORE-TEX® MycroMesh PLUS Biomaterial: named in the summary without a submission number
- (no number) GORE-TEX® DualMesh PLUS Biomaterial with Holes: named in the summary without a submission number
- (no number) GORE-TEX® Soft Tissue Patch: named in the summary without a submission number
- (no number) GORE-TEX® DualMesh Biomaterial: named in the summary without a submission number
- (no number) GORE-TEX® MycroMesh Biomaterial: named in the summary without a submission number
- (no number) GORE-TEX® DualMesh Biomaterial with Holes: named in the summary without a submission number

## Most influential descendants
- K981051: Soft Tissue Patch Plus, Dualmesh Plus, Mycromesh Plus, Dualmesh Plus with Holes (1998), 1 descendant of its own
- K032168: Gore-Tex Dualmesh Emerge Plus Biomaterial (2003), 0 descendants of its own

## Indications for use
The devices are indicated for use in the reconstruction of hernias and softs/tissue deficiencies and for the temporary bridging of fascial defects.

Source page: https://510kreport.com/device/K965038
Methodology: https://510kreport.com/methodology