Cleared Traditional

EVAC

K243205 · Phasor Health, LLC · Neurology
Jun 2025
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K243205 is an FDA 510(k) clearance for the EVAC, 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 June 3, 2025, 245 days after receiving the submission on October 1, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K243205 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date June 03, 2025
Days to Decision 245 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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