Cleared Traditional

HERNIA MESH INTRODUCTION SYSTEM (K945060) - FDA 510(k) Clearance

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

K945060 · Gerard Medical, Inc. · General & Plastic Surgery device
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Mar 1995
Decision
139d
Days
Class 2
Risk

K945060 is an FDA 510(k) clearance for the HERNIA MESH INTRODUCTION SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Gerard Medical, Inc. (Charlton, US). The FDA issued a Cleared decision on March 2, 1995 after a review of 139 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 Gerard Medical, Inc. devices

Submission Details

510(k) Number K945060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date March 02, 1995
Days to Decision 139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
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 131
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K945060.
GORE-TEX SOFT TISSUE PATCH
K951700 · W.L. Gore & Associates, Inc. · Oct 1995
GORE-TEX DUALMESH PLUS BIOMATERIAL
K946106 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX MYCROMESH PLUS BIOMATERIAL
K946107 · W.L. Gore & Associates, Inc. · Apr 1995
GORE-TEX(R) CURVED SURGICALMEMBRANE
K945899 · W.L. Gore & Associates, Inc. · Feb 1995
GORE-TEX SOFT TISSUE PATCH PLUS
K922452 · W.L. Gore & Associates, Inc. · Sep 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822 · W.L. Gore & Associates, Inc. · Jan 1994