Cleared Special

K992189 - GORE-TEX DUALMESH BIOMATERIAL

K992189 is the FDA 510(k) clearance for GORE-TEX DUALMESH BIOMATERIAL 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 30-day FDA review.

K992189 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
30d
Days
Class 2
Risk

K992189 is an FDA 510(k) clearance for the GORE-TEX DUALMESH BIOMATERIAL. 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 July 29, 1999 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 K992189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1999
Decision Date July 29, 1999
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
Combination Product No
PCCP Authorized No
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 187
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K992189.
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · W.L. Gore & Associates, Inc. · Feb 2000
ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
K992991 · Atrium Medical Corp. · Jan 2000
PARIETENE POLYPROPYLENE MESH
K991400 · Sofradim Production · Jul 1999
MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH
K984220 · Ethicon, Inc. · Feb 1999
MESH, SURGICAL, POLYMERIC
K982575 · United States Surgical, A Division of Tyco Healthc · Nov 1998