Cleared Traditional

K232567 - Myriad SPECTRA Light Source (FDA 510(k) Clearance)

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

K232567 · Nico Corporation · Neurology device
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Optimized for regulatory review, auditing and printing
Mar 2024
Decision
203d
Days
Class 2
Risk

K232567 is an FDA 510(k) clearance for the Myriad SPECTRA Light Source. Classified as Diagnostic Neurosurgical Microscope Filter (product code QFX), Class II - Special Controls.

Submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on March 14, 2024 after a review of 203 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4950 - 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.

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Submission Details

510(k) Number K232567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2023
Decision Date March 14, 2024
Days to Decision 203 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
55d slower than avg
Panel avg: 148d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFX Diagnostic Neurosurgical Microscope Filter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4950
Definition A Diagnostic Neurosurgical Microscope Filter Is A Device Intended For Use During Neurosurgery To Visualize Fluorescence And Enhance Visualization Of Tissue Associated With A Specific Disease Or Condition.
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.