Cleared Traditional

K033395 - CODMAN DURAL GRAFT IMPLANT

K033395 is the FDA 510(k) clearance for CODMAN DURAL GRAFT IMPLANT by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code GXO) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K033395 · Codman & Shurtleff, Inc. · Neurology device
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Feb 2004
Decision
125d
Days
Class 2
Risk

K033395 is an FDA 510(k) clearance for the CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-147.... Classified as Strip, Craniosynostosis, Preformed (product code GXO), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on February 25, 2004 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5900 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K033395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date February 25, 2004
Days to Decision 125 days
Submission Type Traditional
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
23d faster than avg
Panel avg: 148d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXO Strip, Craniosynostosis, Preformed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5900
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.