# K031850: Durasis Dural Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Sep 8, 2003 after 84 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: 3 generations back to K921895 (1992). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 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.
- K910555: Tutoplast Dura, Pfrimmer-Viggo GmbH & Co. (1992) Summary page 1.
- K991413: Codman Ethisorb Dura Patch, Johnson & Johnson Professionals, Inc. (2000) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K982180: Duragen Dural Graft Matrix, Integra Lifesciences Corp. (1999) Summary page 1.

## Most influential descendants
- K160869: Biodesign Tissue Graft, Biodesign Dural Graft,  Biodesign Peyronie's Repair Graft (2016), 0 descendants of its own
- K131015: Biodesign Onlay Dural Graft or Biodesign Duraplasty Graft (2013), 0 descendants of its own

## Indications for use
Durasis' Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.

Source page: https://510kreport.com/device/K031850
Methodology: https://510kreport.com/methodology