Cleared Traditional

BIOMESH P1 AND BIOMESH PLUG AND PATCH (K002479) - FDA 510(k) Clearance

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

K002479 · Cousin Biotech S.A.R.L · General & Plastic Surgery device
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Oct 2000
Decision
69d
Days
Class 2
Risk

K002479 is an FDA 510(k) clearance for the BIOMESH P1 AND BIOMESH PLUG AND PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Cousin Biotech S.A.R.L (Washington, US). The FDA issued a Cleared decision on October 19, 2000 after a review of 69 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.

View all Cousin Biotech S.A.R.L devices

Submission Details

510(k) Number K002479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2000
Decision Date October 19, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
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 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K002479.
IVS TUNNELLER
K010035 · United States Surgical, A Division of Tyco Healthc · Apr 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · W.L. Gore & Associates, Inc. · Feb 2001
VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH
K002672 · Ethicon, Inc. · Nov 2000
COMPOSIX E/X MESH
K002684 · C.R. Bard, Inc. · Oct 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc. · May 2000
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
K000185 · W.L. Gore & Associates, Inc. · Feb 2000