Cleared Traditional

K141560 - ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOS...

K141560 is the FDA 510(k) clearance for ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOS... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K141560 · Ethicon, Inc. · General & Plastic Surgery device
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Oct 2014
Decision
133d
Days
Class 2
Risk

K141560 is an FDA 510(k) clearance for the ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on October 23, 2014 after a review of 133 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 Ethicon, Inc. devices

Submission Details

510(k) Number K141560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2014
Decision Date October 23, 2014
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 135
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K141560.
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc. · Sep 2015
Modified ONFLEX Mesh
K142706 · C.R. Bard, Inc. · Mar 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc. · Mar 2015
ULTRAPRO COMFORT PLUG
K133198 · Ethicon, Inc. · May 2014
BARD VENTRALEX HERNIA PATCH
K132441 · C.R. Bard, Inc. · Dec 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968 · C.R. Bard, Inc. · May 2013