Cleared Traditional

K060973 - VYCOR SURGICAL ACCESS SYSTEMS

K060973 is an FDA 510(k) clearance for VYCOR SURGICAL ACCESS SYSTEMS, manufactured by Vycor Medical, LLC. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K060973 · Vycor Medical, LLC · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2006
Decision
107d
Days
Class 2
Risk

K060973 is an FDA 510(k) clearance for the VYCOR SURGICAL ACCESS SYSTEMS. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Vycor Medical, LLC (Shelton, US). The FDA issued a Cleared decision on July 26, 2006 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vycor Medical, LLC devices

FDA 510(k) Submission Details - K060973

510(k) Number K060973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2006
Decision Date July 26, 2006
Days to Decision 107 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
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 Neurology devices follow this clearance model.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 23
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K060973.
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272 · Cardinal Health, Inc. · Mar 2009
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006
GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
K060097 · KLS-Martin L.P. · Feb 2006
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · Spinal Concepts, Inc. · Apr 2005
THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM
K992898 · Bright Medical Instruments · Oct 1999