Cleared Traditional

K061533 - PROCEED VENTRAL PATCH

K061533 is the FDA 510(k) clearance for PROCEED VENTRAL PATCH by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K061533 · Ethicon, Inc. · General & Plastic Surgery device
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Dec 2006
Decision
192d
Days
Class 2
Risk

K061533 is an FDA 510(k) clearance for the PROCEED VENTRAL PATCH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Sommerville, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 192 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon, Inc. devices

Submission Details

510(k) Number K061533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date December 11, 2006
Days to Decision 192 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
77d slower than avg
Panel avg: 115d · This submission: 192d
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 K061533.
ULTRAPRO PLUG
K070224 · Ethicon, Inc. · Apr 2007
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS
K070644 · W.L. Gore & Associates, Inc. · Apr 2007
ATRIUM PROLITE ULTRA S MESH
K070192 · Atrium Medical Corp. · Mar 2007
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006
SURGICAL MESH SYSTEM
K053215 · Nuvasive, Inc. · Jul 2006