# K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 21, 2003 after 41 days
- Product code: FTM (Mesh, Surgical)
- 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: 5 generations back to K842066 (1985). 18 ancestors in all.
143 later devices descend from it; 3 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001789: Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2000)
- K014183: Afb (Absorbable Foam Buttress), J&J Corporate Biomaterials Center (2002)
- K013346: Gore Drapeable ST/LT Regenerative Membrane, W. L. Gore & Associates, Inc. (2001)
- K926167: Polyviolene Suture-Revised Labeling, Look, Inc. (1993) Summary page 2.

## Most influential descendants
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), 69 descendants of its own
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own
- K103263: Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE Technology (2010), 45 descendants of its own

## Indications for use
SEAMGUARD Bioabsorbable Staple Line Reinforcement Material is indicated for surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. SEAMGUARD Bioabsorbable Staple Line Reinforcement Material can be used for reinforcement of staple lines during lung resection and for reinforcement of gastric staple lines during bariatric surgical procedures of gastric bypass and gastric banding.

Source page: https://510kreport.com/device/K030782
Methodology: https://510kreport.com/methodology