Cleared Traditional

K090858 - PARIETEX MONOFILAMENT POLYESTER MESH

K090858 is the FDA 510(k) clearance for PARIETEX MONOFILAMENT POLYESTER 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 37-day FDA review.

K090858 · Sofradim Production · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2009
Decision
37d
Days
Class 2
Risk

K090858 is an FDA 510(k) clearance for the PARIETEX MONOFILAMENT POLYESTER 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 May 6, 2009 after a review of 37 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.

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Submission Details

510(k) Number K090858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date May 06, 2009
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 K090858.
BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
K091659 · C.R. Bard, Inc. · Aug 2009
C-QUR V -PATCH MESH
K090909 · Atrium Medical Corp. · Jun 2009
PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
K090934 · American Medical Systems, Inc. · Jun 2009
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc. · Mar 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc. · Jan 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp. · Jan 2009