Cleared Traditional

K131658 - GORE SEAMGUARD REINFORCEMENT (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K131658 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
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Sep 2013
Decision
92d
Days
Class 2
Risk

K131658 is an FDA 510(k) clearance for the GORE SEAMGUARD REINFORCEMENT. Classified as Mesh, Surgical, Absorbable, Staple Line Reinforcement (product code OXC), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Elkton, US). The FDA issued a Cleared decision on September 6, 2013 after a review of 92 days - within the typical 510(k) review window.

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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K131658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2013
Decision Date September 06, 2013
Days to Decision 92 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
22d faster than avg
Panel avg: 114d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
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.