Cleared Special

K103568 - RESTORELLE POLYPROPYLENE MESH

Also marketed or referenced as:
RESTORELLE POLYPROPYLENE MESH

K103568 is the FDA 510(k) clearance for RESTORELLE POLYPROPYLENE MESH by Coloplast A/S. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 16-day FDA review.

K103568 · Coloplast A/S · General & Plastic Surgery device
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Dec 2010
Decision
16d
Days
Class 2
Risk

K103568 is an FDA 510(k) clearance for the RESTORELLE POLYPROPYLENE MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Coloplast A/S devices

Submission Details

510(k) Number K103568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2010
Decision Date December 22, 2010
Days to Decision 16 days
Submission Type Special
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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 136
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K103568.
VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
K110820 · C.R. Bard, Inc. · Apr 2011
VENTRIO ST HERNIA PATCH
K101920 · C.R. Bard, Inc. · Mar 2011
VENTRALEX ST HERNIA PATCH
K101928 · C.R. Bard, Inc. · Mar 2011
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
VENTRIO HERNIA PATCH
K100229 · C.R. Bard, Inc. · Apr 2010