Cleared Traditional

K021477 - PRECLUDE MVP DURA SUBSTITUTE

K021477 is an FDA 510(k) clearance for PRECLUDE MVP DURA SUBSTITUTE, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K021477 · W.L. Gore & Associates, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
184d
Days
Class 2
Risk

K021477 is an FDA 510(k) clearance for the PRECLUDE MVP DURA SUBSTITUTE. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on November 8, 2002 after a review of 184 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - 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 W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K021477

510(k) Number K021477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2002
Decision Date November 08, 2002
Days to Decision 184 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
36d slower than avg
Panel avg: 148d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K021477.
CODMAN DURAFORM DURAL GRAFT IMPLANT
K041518 · Codman & Shurtleff, Inc. · Jun 2004
DURAGEN PLUS DURAL GRAFT MATRIX
K032693 · Integra Lifesciences Corp. · Sep 2003
DURASIS DURAL SUBSTITUTE
K031850 · Cook Biotech, Inc. · Sep 2003
SHELHIGH NO-REACT DURA SHIELD
K982101 · Shelhigh, Inc. · May 2000
CODMAN ETHISORB DURA PATCH
K991413 · Johnson & Johnson Professionals, Inc. · Mar 2000
DURAGEN DURAL GRAFT MATRIX
K982180 · Integra Lifesciences Corp. · Jul 1999