# K053202: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material

- Pathway: 510(k) (Special)
- Applicant: W.L. Gore & Associates
- Decided: Dec 7, 2005 after 21 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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.

## Indications for use
The GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material 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® Bioabsorbable Staple Line Reinforcement Material is also intended to be used for reinforcement of suture-lines and staple-lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.

Source page: https://510kreport.com/device/K053202
Methodology: https://510kreport.com/methodology