Cleared Special

K063435 - GORE DUALMESH PLUS BIOMATERIAL GORE MYC...

K063435 is the FDA 510(k) clearance for GORE DUALMESH PLUS BIOMATERIAL GORE MYC... by W.L. Gore & Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 15-day FDA review.

K063435 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
15d
Days
Class 2
Risk

K063435 is an FDA 510(k) clearance for the GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on November 28, 2006 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K063435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date November 28, 2006
Days to Decision 15 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTL Mesh, Surgical, Polymeric

All 187
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K063435.
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · W.L. Gore & Associates, Inc. · Apr 2007
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · Cook Biotech, Inc. · Oct 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006