Cleared Traditional

K091659 - BARD 3DMAX LIGHT MESH

K091659 is the FDA 510(k) clearance for BARD 3DMAX LIGHT MESH by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K091659 · C.R. Bard, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
55d
Days
Class 2
Risk

K091659 is an FDA 510(k) clearance for the BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 0.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Warwick, US). The FDA issued a Cleared decision on August 3, 2009 after a review of 55 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K091659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date August 03, 2009
Days to Decision 55 days
Submission Type Traditional
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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K091659.
TORNIER SURGICAL MESH
K093799 · Tornier, Inc. · Apr 2010
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp. · Jan 2010
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp. · Jun 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · American Medical Systems, Inc. · Jun 2009
PARIETEX MONOFILAMENT POLYESTER MESH
K090858 · Sofradim Production · May 2009