Cleared Traditional

Myriad SPECTRA Light Source

K232567 · Nico Corporation · Neurology
Mar 2024
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K232567 is an FDA 510(k) clearance for the Myriad SPECTRA Light Source, a Diagnostic Neurosurgical Microscope Filter (Class II — Special Controls, product code QFX), submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on March 14, 2024, 203 days after receiving the submission on August 24, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4950.

Submission Details

510(k) Number K232567 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code QFX — Diagnostic Neurosurgical Microscope Filter
Device Class Class II — 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.