# K973706: Dura-Guard-Dural Repair Patch

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Vascular, Inc.
- Decided: Dec 24, 1997 after 86 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
Longest line of descent: 1 generation back to K950956 (1995). 1 ancestor in all.
33 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute, Bio-Vascular, Inc. (1995) Summary page 1.

## Most influential descendants
- K982180: Duragen Dural Graft Matrix (1999), 30 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
- K041000: Durepair Dura Regeneration Matrix (2004), 7 descendants of its own
- K052211: Durepair Dura Regeneration Matrix (2005), 5 descendants of its own

## Indications for use
For use as a dural substitute for the closure of dura mater during neurosurgery.

Source page: https://510kreport.com/device/K973706
Methodology: https://510kreport.com/methodology