Cleared Special

K032693 - DURAGEN PLUS DURAL GRAFT MATRIX

K032693 is the FDA 510(k) clearance for DURAGEN PLUS DURAL GRAFT MATRIX by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code GXQ) cleared through the Special 510(k) pathway after a 28-day FDA review.

K032693 · Integra Lifesciences Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
28d
Days
Class 2
Risk

K032693 is an FDA 510(k) clearance for the DURAGEN PLUS DURAL GRAFT MATRIX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra Lifesciences Corp. devices

Submission Details

510(k) Number K032693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date September 30, 2003
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXQ Dura Substitute

All 20
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K032693.
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · Collagen Matrix, Inc. · Dec 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999