# K152609: GORE SYNECOR Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 11, 2015 after 88 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: 7 generations back to K842066 (1985). 47 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093932: Ethicon Physiomesh, Flexible Composite Mesh, Ethicon GmbH (2010) Summary page 4.
- K081069: Gore Infinit Mesh, W. L. Gore & Associates, Inc. (2008) Summary page 4.
- K033671: Gore Bioabsorbable Mesh, W. L. Gore & Associates, Inc. (2003) Summary page 4.

## Most influential descendants
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K163576: GORE SYNECOR Preperitoneal Biomaterial (2017), 0 descendants of its own

## Indications for use
GORE® SYNECOR Biomaterial is intended for use in the repair of hernias and abdominal wall or thoracic wall soft tissue deficiencies that may require the addition of non-absorbable reinforcing or bridging material.

Source page: https://510kreport.com/device/K152609
Methodology: https://510kreport.com/methodology