Cleared Traditional

K081010 - BARD 3DMAX MESH

K081010 is an FDA 510(k) clearance for BARD 3DMAX MESH, manufactured by Davol Inc., Sub. C. R. Bard, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K081010 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
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Oct 2008
Decision
181d
Days
Class 2
Risk

K081010 is an FDA 510(k) clearance for the BARD 3DMAX MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Davol Inc., Sub. C. R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on October 7, 2008 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Davol Inc., Sub. C. R. Bard, Inc. devices

FDA 510(k) Submission Details - K081010

510(k) Number K081010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2008
Decision Date October 07, 2008
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 198
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K081010.
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
TBD ETHICON MESH
K082216 · Ethicon, Inc. · Sep 2008
PARIETEX COMPOSITE MONO PM MESH
K081126 · Sofradim Production · Aug 2008