Cleared Traditional

K043366 - PERMACOL SURGICAL IMPLANT

K043366 is an FDA 510(k) clearance for PERMACOL SURGICAL IMPLANT, manufactured by Tissue Science Laboratories, Plc. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K043366 · Tissue Science Laboratories, Plc · General & Plastic Surgery device
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Dec 2004
Decision
9d
Days
Class 2
Risk

K043366 is an FDA 510(k) clearance for the PERMACOL SURGICAL IMPLANT. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Tissue Science Laboratories, Plc (Covington, US). The FDA issued a Cleared decision on December 17, 2004 after a review of 9 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 Tissue Science Laboratories, Plc devices

FDA 510(k) Submission Details - K043366

510(k) Number K043366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2004
Decision Date December 17, 2004
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 237
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K043366.
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · Sofradim Production · Feb 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc. · Dec 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc. · Dec 2004
BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004
K042026 · C.R. Bard, Inc. · Sep 2004
MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH
K040998 · Sofradim Production · Apr 2004
ULTRAPRO MESH
K033337 · Ethicon, Inc. · Apr 2004