Cleared Traditional

K081126 - PARIETEX COMPOSITE MONO PM MESH

K081126 is the FDA 510(k) clearance for PARIETEX COMPOSITE MONO PM 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 114-day FDA review.

K081126 · Sofradim Production · General & Plastic Surgery device
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Aug 2008
Decision
114d
Days
Class 2
Risk

K081126 is an FDA 510(k) clearance for the PARIETEX COMPOSITE MONO PM 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 August 13, 2008 after a review of 114 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.

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Submission Details

510(k) Number K081126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2008
Decision Date August 13, 2008
Days to Decision 114 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
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 K081126.
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc. · Sep 2008
TBD ETHICON MESH
K082216 · Ethicon, Inc. · Sep 2008
GORE INFINIT MESH
K081069 · W.L. Gore & Associates, Inc. · May 2008
PARIETEX PROGRIP MESH
K081050 · Sofradim Production · May 2008
C-QUR LITE MESH V-PATCH
K080688 · Atrium Medical Corp. · Apr 2008