Cleared Traditional

VYCOR SURGICAL ACCESS SYSTEMS (K060973) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060973 · Vycor Medical, LLC · Neurology device
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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

Submission Details

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.

Device Classification

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 42
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K060973.
Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
K210615 · Thompson Surgical Instruments, Inc. · May 2022
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
K202694 · Vycor Medical, Inc. · Jan 2021
MindsEye Expandable Port
K202072 · Minnetronix Neuro, Inc. · Aug 2020
Geister retractor for neuro - and spine surgery
K180610 · Geister Medizin Technik GmbH · Aug 2018
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR
K895395 · Baxter Healthcare Corp · Oct 1989