Cleared Traditional

K061754 - BARD COMPOSITE L/P MESH (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K061754 · Davol Inc., Sub. C. R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 114d · This submission: 124d
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 334
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K061754.
Parietene™ Flat Sheet Mesh
K253125 · Medtronic - Sofradim Production · Oct 2025
Onflex™ Mesh
K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jul 2025
Bard® Mesh
K251557 · Davol, Inc. · Jun 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · Sofradim Production · Apr 2025
Bard Soft Mesh
K250098 · Davol, Inc. · Apr 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · Sofradim Production · Jan 2025