# K953969: Preclude Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 1, 1995 after 71 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 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
- K982180: Duragen Dural Graft Matrix (1999), 30 descendants of its own
- K032693: Duragen Plus Dural Graft Matrix (2003), 9 descendants of its own
- K041000: Durepair Dura Regeneration Matrix (2004), 7 descendants of its own
- K052211: Durepair Dura Regeneration Matrix (2005), 5 descendants of its own
- K063117: Modification to Durepair Dura Regeneration Matrix (2006), 3 descendants of its own

Source page: https://510kreport.com/device/K953969
Methodology: https://510kreport.com/methodology