# K131658: Gore Seamguard Reinforcement

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Sep 6, 2013 after 92 days
- Product code: OXC (Mesh, Surgical, Absorbable, Staple Line Reinforcement)
- 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). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2004) Summary page 1.

## Most influential descendants
- K150551: GORE SEAMGUARD Reinforcement (2015), 0 descendants of its own

## Indications for use
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Source page: https://510kreport.com/device/K131658
Methodology: https://510kreport.com/methodology