Cleared Traditional

EVAC-MRI

K252514 · Phasor Health, LLC · Neurology
Nov 2025
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K252514 is an FDA 510(k) clearance for the EVAC-MRI, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Phasor Health, LLC (Houston, US). The FDA issued a Cleared decision on November 5, 2025, 86 days after receiving the submission on August 11, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K252514 FDA.gov
FDA Decision Cleared SESD
Date Received August 11, 2025
Decision Date November 05, 2025
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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