Cleared Special

K041518 - CODMAN DURAFORM DURAL GRAFT IMPLANT

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

K041518 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K041518

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
134d faster than avg
Panel avg: 149d · This submission: 15d
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 K041518.
DURAGEN II DURAL REGENERATION MATRIX
K043427 · Integra Lifesciences Corp. · Jan 2005
DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE
K040888 · Collagen Matrix, Inc. · Dec 2004
DUREPAIR DURA REGENERATION MATRIX
K041000 · Medtronic Neurosurgery · Jul 2004
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · Integra Lifesciences Corp. · Sep 2003
DURASIS DURAL SUBSTITUTE
K031850 · Cook Biotech, Inc. · Sep 2003
PRECLUDE MVP DURA SUBSTITUTE
K021477 · W.L. Gore & Associates, Inc. · Nov 2002
K041518 · CODMAN DURAFORM DURAL GRAFT IMPLANT
Download PDF FDA Summary Codman & Shurtleff, I…