# K010936: Modification to Seamguard Staple Line Reinforcement Material

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 21, 2001 after 54 days
- Product code: OXD (Mesh, Surgical, Non-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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022044: Surgisis Staple Line Reinforcement (2002), 6 descendants of its own
- K051048: Surgisis Staple Line Reinforcement II (2005), 3 descendants of its own
- K021477: Preclude MVP Dura Substitute (2002), 3 descendants of its own
- K113071: Synthecel Dura Replacement Devices (2012), 2 descendants of its own
- K070405: Modification to Surgisis SLR Staple Line Reinforcement (2007), 2 descendants of its own

Source page: https://510kreport.com/device/K010936
Methodology: https://510kreport.com/methodology