Cleared Special

K152481 - DURAFORM Dural Graft Implant

K152481 is the FDA 510(k) clearance for DURAFORM Dural Graft Implant by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

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 15
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K152481.
SyntheCel Dura Repair
K212943 · Synthes USA Products, LLC · Jan 2022
XenoSure Dura Biologic Patch
K183513 · LeMaitre Vascular, Inc. · Jun 2019
DuraGen Secure Dural Regeneration Matrix
K163456 · Integra LifeSciences Corporation · Jan 2017
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
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004