510(k) K250636

Sophy Mini Monopressure Valve (SM1) by Sophysa — Product Code JXG

K250636 is an FDA 510(k) premarket notification submitted by Sophysa for the device "Sophy Mini Monopressure Valve (SM1)". The FDA issued a decision of Substantially Equivalent on November 28, 2025. 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.