Cleared Traditional

BLUE 400; BLUE 400 S

K240215 · Carl Zeiss Meditec, AG · Neurology
Jun 2024
Decision
154d
Days
Class 2
Risk

About This 510(k) Submission

K240215 is an FDA 510(k) clearance for the BLUE 400; BLUE 400 S, a Diagnostic Neurosurgical Microscope Filter (Class II — Special Controls, product code QFX), submitted by Carl Zeiss Meditec, AG (Oberkochen, DE). The FDA issued a Cleared decision on June 28, 2024, 154 days after receiving the submission on January 26, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4950.

Submission Details

510(k) Number K240215 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2024
Decision Date June 28, 2024
Days to Decision 154 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.