DuraGen Plus Dural Graft Matrix
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032693 FDA 510(k)
- FDA Product Code
- GXQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5910 FDA 510(k)
- Regulation Number
- 882.5910 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DuraGen Plus Dural Graft Matrix is a dural substitute device used for the restoration and repair of dura mater. It is made from a controlled collagen source with enhanced porosity and strength, treated with a proprietary process designed to remove antigenic components, resulting in Ultra Pure Collagen.
The device is supplied as an onlay graft and is designed to contour to complex surfaces. It is regulated under FDA 510(k) clearance with product code GXQ and device class 2. The device is manufactured by Integra Lifesciences Corp. and has multiple registration numbers associated with it.
Frequently asked questions
What is the DuraGen Plus Dural Graft Matrix used for?
The DuraGen Plus Dural Graft Matrix is a dural substitute device specifically designed for the restoration and repair of dura mater. It is made from controlled collagen with enhanced porosity and strength, treated to remove antigenic components, resulting in Ultra Pure Collagen.
How is the DuraGen Plus Dural Graft Matrix supplied?
The device is supplied as an onlay graft designed to contour to complex surfaces. It is manufactured by Integra Lifesciences Corp. and comes with multiple registration numbers for regulatory tracking purposes.
What is the regulatory status of the DuraGen Plus Dural Graft Matrix?
The DuraGen Plus Dural Graft Matrix is regulated under FDA 510(k) clearance with product code GXQ and device class 2. It received special clearance as substantially equivalent in 2003 and is associated with the Neurology advisory committee.
What are the key features of the DuraGen Plus Dural Graft Matrix?
The key features include its controlled collagen source with enhanced porosity and strength, proprietary treatment process that removes antigenic components resulting in Ultra Pure Collagen, and its design as an onlay graft that can contour to complex surfaces.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DuraGen® Plus Dural Regeneration Matrix - Integra Life, DuraGen® Dural Graft Matrix - Integra Life, DuraGen Plus - Integra LifeSciences - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032693 | Class II | Active |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA 510(k) K032693 24 fields · synced Sep 28, 2026