Cleared Special

K000185 - GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)

K000185 is an FDA 510(k) clearance for GORE-TEX DUALMESH PLUS BIOMATERIAL (1 M..., manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Special 510(k) pathway after a 25-day FDA review.

K000185 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
25d
Days
Class 2
Risk

K000185 is an FDA 510(k) clearance for the GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM). 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 February 14, 2000 after a review of 25 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

FDA 510(k) Submission Details - K000185

510(k) Number K000185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2000
Decision Date February 14, 2000
Days to Decision 25 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

FTL Device Classification - Class 2, Special Controls

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 300
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K000185.
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
K994328 · Genzyme Corp. · Mar 2000
PERMACOL
K992556 · Tissue Science Laboratories, Plc · Feb 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991 · Atrium Medical Corp. · Jan 2000
STAR TEMPORARY WOUND COVER
K983753 · Osteogenics, Inc. · Nov 1999
GORE-TEX DUALMESH BIOMATERIAL
K992189 · W.L. Gore & Associates, Inc. · Jul 1999