Cleared Special

K061704 - OPTILENE MESH

K061704 is an FDA 510(k) clearance for OPTILENE MESH, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K061704

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.

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 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K061704.
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
BARD COMPOSITE L/P MESH
K061754 · Davol Inc., Sub. C. R. Bard, Inc. · Oct 2006
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT
K062697 · Cook Biotech, Inc. · Oct 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006
BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH
K061314 · Davol Inc., Sub. C. R. Bard, Inc. · Jun 2006
PROCEED SURGICAL MESH
K060713 · Ethicon, Inc. · May 2006