Cleared Traditional

EZ-FIDUCIALS

K250505 · Phasor Health, LLC · Neurology
Jul 2025
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K250505 is an FDA 510(k) clearance for the EZ-FIDUCIALS, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on July 9, 2025, 138 days after receiving the submission on February 21, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K250505 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2025
Decision Date July 09, 2025
Days to Decision 138 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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