Cleared Special

K110815 - PARIETEX OPTIMIZED COMPOSTIE MESH

K110815 is the FDA 510(k) clearance for PARIETEX OPTIMIZED COMPOSTIE MESH by Sofradim Production. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 26-day FDA review.

K110815 · Sofradim Production · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
26d
Days
Class 2
Risk

K110815 is an FDA 510(k) clearance for the PARIETEX OPTIMIZED COMPOSTIE MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Sofradim Production (Bedford, US). The FDA issued a Cleared decision on April 19, 2011 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sofradim Production devices

Submission Details

510(k) Number K110815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2011
Decision Date April 19, 2011
Days to Decision 26 days
Submission Type Special
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
89d faster than avg
Panel avg: 115d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 K110815.
RENASYS AB ABOMINAL DRESSING KIT
K112784 · Smith & Nephew, Inc. · Nov 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663 · Sofradim Production · Aug 2011
TORNIER BIOFIBER SCAFFOLD
K102788 · Tornier, Inc. · May 2011
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
K110816 · Sofradim Production · Apr 2011
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
K110820 · C.R. Bard, Inc. · Apr 2011
VENTRIO ST HERNIA PATCH
K101920 · C.R. Bard, Inc. · Mar 2011