Cleared Traditional

K053158 - OPTILENE MESH LP

K053158 is the FDA 510(k) clearance for OPTILENE MESH LP by Aesculap, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K053158 · Aesculap, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2006
Decision
65d
Days
Class 2
Risk

K053158 is an FDA 510(k) clearance for the OPTILENE MESH LP. 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 January 18, 2006 after a review of 65 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 Aesculap, Inc. devices

Submission Details

510(k) Number K053158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date January 18, 2006
Days to Decision 65 days
Submission Type Traditional
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
50d faster than avg
Panel avg: 115d · This submission: 65d
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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K053158.
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
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005