510(k) K222422

Polaris Valve Electronic Reading Instrument by Sophysa — Product Code JXG

K222422 is an FDA 510(k) premarket notification submitted by Sophysa for the device "Polaris Valve Electronic Reading Instrument". The FDA issued a decision of Substantially Equivalent on February 2, 2023. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Sophysa has at least 10 other 510(k) clearances on record.