Cleared Special

K061704 - OPTILENE MESH

K061704 is the FDA 510(k) clearance for OPTILENE MESH by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Special 510(k) pathway after a 33-day FDA review.

K061704 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
33d
Days
Class 2
Risk

K061704 is an FDA 510(k) clearance for the OPTILENE MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 19, 2006 after a review of 33 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 Aesculap, Inc. devices

Submission Details

510(k) Number K061704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2006
Decision Date July 19, 2006
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K061704.
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006
PROCEED SURGICAL MESH
K060713 · Ethicon, Inc. · May 2006
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · Atrium Medical Corp. · Mar 2006