Cleared Special

K041518 - CODMAN DURAFORM DURAL GRAFT IMPLANT

K041518 is the FDA 510(k) clearance for CODMAN 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 15-day FDA review.

K041518 · Codman & Shurtleff, Inc. · Neurology device
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Jun 2004
Decision
15d
Days
Class 2
Risk

K041518 is an FDA 510(k) clearance for the CODMAN 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 June 22, 2004 after a review of 15 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 K041518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date June 22, 2004
Days to Decision 15 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
133d faster than avg
Panel avg: 148d · This submission: 15d
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 K041518.
DURAFORM Dural Graft Implant
K152481 · Codman & Shurtleff, Inc. · Oct 2015
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
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999