Cleared Traditional

K032865 - GORE SEAMGUARD BIOABSORBABLE STAPLE LIN...

K032865 is the FDA 510(k) clearance for GORE SEAMGUARD BIOABSORBABLE STAPLE LIN... by W.L. Gore & Associates, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K032865 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
77d
Days
Class 2
Risk

K032865 is an FDA 510(k) clearance for the GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on November 28, 2003 after a review of 77 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K032865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2003
Decision Date November 28, 2003
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 187
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K032865.
ULTRAPRO MESH
K033337 · Ethicon, Inc. · Apr 2004
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
K033814 · C.R. Bard, Inc. · Mar 2004
UGYTEX MESH
K033376 · Sofradim Production · Jan 2004
PROCEED TRILAMINATE SURGICAL MESH
K031925 · Ethicon, Inc. · Sep 2003
GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL
K032168 · W.L. Gore & Associates, Inc. · Aug 2003
V.A.C. ABDOMINAL DRESSING
K022011 · Kinetic Concepts, Inc. · Feb 2003