# K152481: DURAFORM Dural Graft Implant

- Pathway: 510(k) (Special)
- Applicant: Codman & Shurtleff, Inc.
- Decided: Oct 30, 2015 after 60 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: 4 generations back to K950956 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033395: Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1, Codman & Shurtleff, Inc. (2004) Summary page 4.

## Recalls of this device
- Sep 26, 2024 · Class II · Z-0262-2025: Out of specification endotoxin levels.

## Indications for use
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.

Source page: https://510kreport.com/device/K152481
Methodology: https://510kreport.com/methodology