Cleared Traditional

K063739 - SEPRAMESH

K063739 is the FDA 510(k) clearance for SEPRAMESH by Genzyme Corporation. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K063739 · Genzyme Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
30d
Days
Class 2
Risk

K063739 is an FDA 510(k) clearance for the SEPRAMESH, MODEL 5959-1214. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on January 17, 2007 after a review of 30 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 Genzyme Corporation devices

Submission Details

510(k) Number K063739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2006
Decision Date January 17, 2007
Days to Decision 30 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
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 186
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K063739.
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
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc. · Dec 2006
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K063435 · W.L. Gore & Associates, Inc. · Nov 2006
OPTILENE MESH
K061704 · Aesculap, Inc. · Jul 2006