Cleared Traditional

Polaris Valve Electronic Reading Instrument

K222422 · Sophysa · Neurology
Feb 2023
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K222422 is an FDA 510(k) clearance for the Polaris Valve Electronic Reading Instrument, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Sophysa (Orsay, FR). The FDA issued a Cleared decision on February 2, 2023, 175 days after receiving the submission on August 11, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K222422 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2022
Decision Date February 02, 2023
Days to Decision 175 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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