Cleared Traditional

K052155 - BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED

K052155 is an FDA 510(k) clearance for BARD LARGE PORE SOFT MESH AND SOFT MESH..., manufactured by 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 73-day FDA review.

K052155 · C.R. Bard, Inc. · General & Plastic Surgery device
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Oct 2005
Decision
73d
Days
Class 2
Risk

K052155 is an FDA 510(k) clearance for the BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Canston, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 73 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

FDA 510(k) Submission Details - K052155

510(k) Number K052155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2005
Decision Date October 20, 2005
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
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 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K052155.
CALDERA MESH
K060004 · Caldera Medical, Inc. · Feb 2006
OPTILENE MESH LP
K053158 · Aesculap, Inc. · Jan 2006
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
INCLOSE SURGICAL MESH SYSTEM
K050969 · Anulex Technologies, Inc. · Aug 2005
ORTHOMEND
K051766 · Tei Biosciences, Inc. · Aug 2005