Cleared Traditional

K101519 - PARIETEX PLUG AND PATCH

K101519 is an FDA 510(k) clearance for PARIETEX PLUG AND PATCH, manufactured by Sofradim Production. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K101519 · Sofradim Production · General & Plastic Surgery device
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Nov 2010
Decision
156d
Days
Class 2
Risk

K101519 is an FDA 510(k) clearance for the PARIETEX PLUG AND PATCH. 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 November 5, 2010 after a review of 156 days - an extended review 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: 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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FDA 510(k) Submission Details - K101519

510(k) Number K101519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2010
Decision Date November 05, 2010
Days to Decision 156 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
41d slower than avg
Panel avg: 115d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

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 273
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K101519.
ATRIUM CENTRILFX MESH
K110110 · Atrium Medical Corporation · Feb 2011
RESTORELLE POLYPROPYLENE MESH
K103568 · Coloplast A/S · Dec 2010
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM
K102766 · C.R. Bard, Inc. · Dec 2010
RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT
K100787 · Smith & Nephew, Inc. · Sep 2010
ASCEND BLUE AC MESH
K101462 · Caldera Medical, Inc. · Aug 2010
VENTRALIGHT ST MESH
K101851 · Davol Inc., Sub. C. R. Bard, Inc. · Jul 2010