Cleared Special

GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL (K032168) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032168 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
30d
Days
Class 2
Risk

K032168 is an FDA 510(k) clearance for the GORE-TEX DUALMESH EMERGE 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 August 15, 2003 after a review of 30 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 K032168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2003
Decision Date August 15, 2003
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 96
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K032168.
ULTRAPRO MESH
K033337 · Ethicon, Inc. · Apr 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814 · C.R. Bard, Inc. · Mar 2004
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc. · Sep 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc. · Feb 2003
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc. · Aug 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · C.R. Bard, Inc. · Jul 2002