Cleared Traditional

K060713 - PROCEED SURGICAL MESH

K060713 is an FDA 510(k) clearance for PROCEED SURGICAL MESH, manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K060713 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
69d
Days
Class 2
Risk

K060713 is an FDA 510(k) clearance for the PROCEED SURGICAL MESH. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on May 25, 2006 after a review of 69 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 Ethicon, Inc. devices

FDA 510(k) Submission Details - K060713

510(k) Number K060713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date May 25, 2006
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K060713.
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 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
ATRIUM MEDICAL CORPORATION C-QUR MESH
K050311 · Atrium Medical Corp. · Mar 2006
POPMESH
K053424 · Caldera Medical, Inc. · Feb 2006
CALDERA MESH
K060004 · Caldera Medical, Inc. · Feb 2006