510(k) K992465

SOPHY SU8 PRESSURE ADJUSTABLE VALVE by Sophysa SA — Product Code JXG

K992465 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "SOPHY SU8 PRESSURE ADJUSTABLE VALVE". The FDA issued a decision of Substantially Equivalent on September 21, 2000. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Sophysa SA has at least 10 other 510(k) clearances on record.