# K982180: Duragen Dural Graft Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Integra Lifesciences Corp.
- Decided: Jul 6, 1999 after 379 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). 5 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970851: Lyoplant Dura Substitute (Various), Aesculap, Inc. (1997) Summary page 1.
- K973706: Dura-Guard-Dural Repair Patch, Bio-Vascular, Inc. (1997) Summary page 1.
- K953969: Preclude Dura Substitute, W. L. Gore & Associates, Inc. (1995). Our OCR of the scanned summary read K953967, FDA’s number for Endoscopic Catheter (Act Medical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Preclude® Dura Substitute”.
- K910555: Tutoplast Dura, Pfrimmer-Viggo GmbH & Co. (1992) Summary page 2.
- (no number) Lyodura®: named in the summary without a submission number

## Most influential descendants
- 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
- K043427: Duragen II Dural Regeneration Matrix (2005), 3 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1282-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

## Indications for use
DuraGen™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

Source page: https://510kreport.com/device/K982180
Methodology: https://510kreport.com/methodology