Cleared Traditional

K142091 - PARIETENE MACROPOROUS MESH

K142091 is the FDA 510(k) clearance for PARIETENE MACROPOROUS MESH by Sofradim Production. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K142091 · Sofradim Production · General & Plastic Surgery device
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Oct 2014
Decision
77d
Days
Class 2
Risk

K142091 is an FDA 510(k) clearance for the PARIETENE MACROPOROUS MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sofradim Production (North Haven, US). The FDA issued a Cleared decision on October 17, 2014 after a review of 77 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 Sofradim Production devices

Submission Details

510(k) Number K142091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2014
Decision Date October 17, 2014
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K142091.
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
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
ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE
K141560 · Ethicon, Inc. · Oct 2014
ULTRAPRO COMFORT PLUG
K133198 · Ethicon, Inc. · May 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941 · Sofradim Production · May 2014
BARD VENTRALEX HERNIA PATCH
K132441 · C.R. Bard, Inc. · Dec 2013