Cleared Special

GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES (K010228) - FDA 510(k) Clearance

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

K010228 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
28d
Days
Class 2
Risk

K010228 is an FDA 510(k) clearance for the GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 28 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 K010228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2001
Decision Date February 21, 2001
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 106
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K010228.
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · C.R. Bard, Inc. · Jul 2002
PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH
K010722 · Ethicon, Inc. · Apr 2001
IVS TUNNELLER
K010035 · United States Surgical, A Division of Tyco Healthc · Apr 2001
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · Ethicon, Inc. · Nov 2000
COMPOSIX E/X MESH
K002684 · C.R. Bard, Inc. · Oct 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000