Cleared Traditional

K081591 - NEUCODIA

K081591 is an FDA 510(k) clearance for NEUCODIA, manufactured by Verisci Corporation. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K081591 · Verisci Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
343d
Days
Class 2
Risk

K081591 is an FDA 510(k) clearance for the NEUCODIA. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Verisci Corporation (Raritan, US). The FDA issued a Cleared decision on May 15, 2009 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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. Elevated predicate reliance profile. 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 - K081591

510(k) Number K081591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2008
Decision Date May 15, 2009
Days to Decision 343 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
194d slower than avg
Panel avg: 149d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 43
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K081591.
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K081591 · NEUCODIA
Download PDF FDA Summary Verisci Corporation