Cleared Traditional

K202694 - Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) (FDA 510(k) Clearance)

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

K202694 · Vycor Medical, Inc. · Neurology device
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Jan 2021
Decision
120d
Days
Class 2
Risk

K202694 is an FDA 510(k) clearance for the Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment C.... Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Vycor Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on January 14, 2021 after a review of 120 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, Inc. devices

Submission Details

510(k) Number K202694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2020
Decision Date January 14, 2021
Days to Decision 120 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 148d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Mdi Consultant, Inc.
Maria Griffin

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.