Cleared Traditional

K040888 - DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE

K040888 is an FDA 510(k) clearance for DURAMATRIX COLLAGEN DURA SUBSTITUTE MEM..., manufactured by Collagen Matrix, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K040888

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.

GXQ Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K040888.
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE
K061487 · Collagen Matrix, Inc. · Jun 2006
DUREPAIR DURA REGENERATION MATRIX
K052211 · Medtronic Neurosurgery · Sep 2005
DURAGEN II DURAL REGENERATION MATRIX
K043427 · Integra Lifesciences Corp. · Jan 2005
DUREPAIR DURA REGENERATION MATRIX
K041000 · Medtronic Neurosurgery · Jul 2004
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · Integra Lifesciences Corp. · Sep 2003