Cleared Traditional

K142711 - ONFLEX Mesh

K142711 is an FDA 510(k) clearance for ONFLEX 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 179-day FDA review.

K142711 · C.R. Bard, Inc. · General & Plastic Surgery device
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Mar 2015
Decision
179d
Days
Class 2
Risk

K142711 is an FDA 510(k) clearance for the ONFLEX Mesh. 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 March 20, 2015 after a review of 179 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K142711

510(k) Number K142711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date March 20, 2015
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
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 209
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K142711.
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
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K142908 · Sofradim Production · Nov 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
K142900 · Sofradim Production · Oct 2014