Cleared Traditional

K040888 - DURAMATRIX COLLAGEN DURA SUBSTITUTE MEM...

K040888 is the FDA 510(k) clearance for DURAMATRIX COLLAGEN DURA SUBSTITUTE MEM... by Collagen Matrix, Inc.. It is a Class 2 Neurology device (product code GXQ) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K040888 · Collagen Matrix, Inc. · Neurology device
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Dec 2004
Decision
240d
Days
Class 2
Risk

K040888 is an FDA 510(k) clearance for the DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 240 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Collagen Matrix, Inc. devices

Submission Details

510(k) Number K040888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date December 01, 2004
Days to Decision 240 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 148d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 19
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K040888.
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
K092388 · Integra LifeSciences Corporation · Jan 2010
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
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