510(k) K013488

SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 by Sophysa SA — Product Code JXG

K013488 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8". The FDA issued a decision of Substantially Equivalent on March 27, 2002. 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.