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

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

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.

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

89d faster than avg

Panel avg: 149d · 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 42

Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K152481.

Cerafix Dura Substitute

K161278 · Acera Surgical, Inc. · Aug 2016

Cerafix Dura Substitute

K153613 · Acera Surgical, Inc. · Mar 2016

Collagen Dural Regeneration Matrix

K150825 · Collagen Matrix, Inc. · Nov 2015

COLLAGEN DURA MEMBRANE

K141608 · Collagen Matrix, Inc. · Jan 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

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.