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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 149d · 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 Consultant

Tuv Rheinland of North America, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 42
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K060973.
INSTRUMED RETRACTORS
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K071338 · Koros USA, Inc. · May 2007
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
K060973 · VYCOR SURGICAL ACCESS SYSTEMS
Download PDF FDA Summary Vycor Medical, LLC