# K963619: Gore-Tex Soft Tissue Patch,Mycromesha Biomaterial,Dualmesh Biomaterial,Dualmesh Biomaterial with Holes

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Oct 25, 1996 after 45 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 K810428 (1981). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830889: Dexon 'S' Polyglycolic Acid Mesh, Davis & Geck, Inc. (1983) Summary page 1.
- K810428: Vicryl, ETHICON, Inc. (1981) Summary page 1.
- (no number) GORE-TEX® Soft Tissue Patch: 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: named in the summary without a submission number
- (no number) GORE-TEX® DualMesh Biomaterial with Holes: named in the summary without a submission number

## Indications for use
The applicant devices are intended to be used for the reconstruction of hernias and for the temporary bridging of fascial defects and soft tissue deficiencies.

Source page: https://510kreport.com/device/K963619
Methodology: https://510kreport.com/methodology