Cleared Special

K152481 - DURAFORM Dural Graft Implant

K152481 is an FDA 510(k) clearance for DURAFORM Dural Graft Implant, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Special 510(k) pathway after a 60-day FDA review.

K152481 · Codman & Shurtleff, Inc. · Neurology device
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Oct 2015
Decision
60d
Days
Class 2
Risk

K152481 is an FDA 510(k) clearance for the DURAFORM Dural Graft Implant. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 60 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 Codman & Shurtleff, Inc. devices

FDA 510(k) Submission Details - K152481

510(k) Number K152481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2015
Decision Date October 30, 2015
Days to Decision 60 days
Submission Type Special
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
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 34
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K152481.
DuraGen Secure Dural Regeneration Matrix
K163456 · Integra LifeSciences Corporation · Jan 2017
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery · Nov 2016
Collagen Dural Regeneration Matrix
K150825 · Collagen Matrix, Inc. · Nov 2015
COLLAGEN DURA MEMBRANE
K141608 · Collagen Matrix, Inc. · Jan 2015
BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
K131015 · Cook Biotech, Inc. · Oct 2013
LYOPLANT ONLAY
K122791 · Aesculap, Inc. · Jun 2013