# K053200: Gore Seamguard Staple Line Reinforcement Material

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- 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: 1 (0 Class I)
- 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
- K070644: Gore  Seamguard Staple Line Reinforcement Material for Circular Staplers (2007), 0 descendants of its own

## Recalls of this device
- Jul 3, 2024 · Class II · Z-2513-2024: Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

## Indications for use
The GORE SEAMGUARD Staple Line Reinforcement Material for Circular Staplers is indicated for use in surgical procedures in which a soft tissue anastomosis with staple line reinforcement is needed. GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during bariatric, colon, colorectal, gastric, and small bowel procedures.

Source page: https://510kreport.com/device/K053200
Methodology: https://510kreport.com/methodology