# K982282: Dura-Guard - Dural Repair Patch

- Pathway: 510(k) (Special)
- Applicant: Bio-Vascular, Inc.
- Decided: Jul 30, 1998 after 30 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950956 (1995). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973706: Dura-Guard-Dural Repair Patch, Bio-Vascular, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K161370: Durepair Dura Regeneration Matrix (2016), 2 descendants of its own
- K113071: Synthecel Dura Replacement Devices (2012), 2 descendants of its own

## Recalls of this device
- Oct 28, 2013 · Class II · Z-0339-2014: Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipmen

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

Source page: https://510kreport.com/device/K982282
Methodology: https://510kreport.com/methodology