# K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Jun 2, 1995 after 92 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.
43 later devices descend from it; 6 cite it directly.
0 of 44 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
- K973706: Dura-Guard-Dural Repair Patch (1997), 33 descendants of its own
- K982180: Duragen Dural Graft Matrix (1999), 30 descendants of its own
- K991413: Codman Ethisorb Dura Patch (2000), 14 descendants of its own
- K982282: Dura-Guard - Dural Repair Patch (1998), 13 descendants of its own
- K032693: Duragen Plus Dural Graft Matrix (2003), 9 descendants of its own

Source page: https://510kreport.com/device/K950956
Methodology: https://510kreport.com/methodology