Cleared Traditional

K061754 - BARD COMPOSITE L/P MESH

K061754 is an FDA 510(k) clearance for BARD COMPOSITE L/P 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 124-day FDA review.

K061754 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
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Oct 2006
Decision
124d
Days
Class 2
Risk

K061754 is an FDA 510(k) clearance for the BARD COMPOSITE L/P 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 23, 2006 after a review of 124 days - within the typical 510(k) review window.

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 - K061754

510(k) Number K061754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2006
Decision Date October 23, 2006
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 K061754.
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · Cook Biotech, Inc. · Oct 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006