510(k) K091328

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE by Sophysa SA — Product Code JXG

K091328 is an FDA 510(k) premarket notification submitted by Sophysa SA for the device "SIPHONX GRAVITATIONAL ANTISIPHON DEVICE". The FDA issued a decision of Substantially Equivalent on January 22, 2010. 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.