Cleared Traditional

K141608 - COLLAGEN DURA MEMBRANE

K141608 is an FDA 510(k) clearance for COLLAGEN DURA MEMBRANE, 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 214-day FDA review.

K141608 · Collagen Matrix, Inc. · Neurology device
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Jan 2015
Decision
214d
Days
Class 2
Risk

K141608 is an FDA 510(k) clearance for the COLLAGEN DURA MEMBRANE. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on January 16, 2015 after a review of 214 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 - K141608

510(k) Number K141608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date January 16, 2015
Days to Decision 214 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
66d slower than avg
Panel avg: 148d · This submission: 214d
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 K141608.
Cerafix Dura Substitute
K153613 · Acera Surgical, Inc. · Mar 2016
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc. · Nov 2015
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
K132850 · Rti Surgical, Inc. · Mar 2014
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K131792 · Synthes, Inc. · Dec 2013
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc. · Oct 2013