Cleared Abbreviated

GORE INFINIT MESH (K081069) - FDA 510(k) Clearance

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

K081069 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
45d
Days
Class 2
Risk

K081069 is an FDA 510(k) clearance for the GORE INFINIT MESH. 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 May 30, 2008 after a review of 45 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K081069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2008
Decision Date May 30, 2008
Days to Decision 45 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
Pathway characteristics
Standards-based clearance path.

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 K081069.
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659 · C.R. Bard, Inc. · Aug 2009
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
TBD ETHICON MESH
K082216 · Ethicon, Inc. · Sep 2008
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249 · Ethicon, Inc. · Jun 2007
ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006