Cleared Traditional

K133889 - PREMIUM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133889 · Cousin Biotech Sas · General & Plastic Surgery device
Sep 2014
Decision
258d
Days
Class 2
Risk

K133889 is an FDA 510(k) clearance for the PREMIUM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Cousin Biotech Sas (Wervicq-Sud, FR). The FDA issued a Cleared decision on September 4, 2014 after a review of 258 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.

Submission Details

510(k) Number K133889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2013
Decision Date September 04, 2014
Days to Decision 258 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 132d · This submission: 258d
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 10
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K133889.
Parietene™ Flat Sheet Mesh
K253125 · Medtronic - Sofradim Production · Oct 2025
Onflex™ Mesh
K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc. · Jul 2025
Bard® Mesh
K251557 · Davol, Inc. · Jun 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · Sofradim Production · Apr 2025
Bard Soft Mesh
K250098 · Davol, Inc. · Apr 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · Sofradim Production · Jan 2025