# K170134: Reperen Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Iconlab, Inc.
- Decided: Aug 9, 2017 after 204 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 K992189 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992189: Gore-Tex Dualmesh Biomaterial, W. L. Gore & Associates, Inc. (1999) Summary page 4.

## Indications for use
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects.

Source page: https://510kreport.com/device/K170134
Methodology: https://510kreport.com/methodology