# K163576: GORE SYNECOR Preperitoneal Biomaterial

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 11, 2017 after 143 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: 8 generations back to K842066 (1985). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152609: GORE SYNECOR Biomaterial, W. L. Gore & Associates, Inc. (2015) Summary page 4.

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

Source page: https://510kreport.com/device/K163576
Methodology: https://510kreport.com/methodology