510(k) K040470

TRIPTER X-1 COMPACT by Direx Systems Corp. — Product Code LNS

K040470 is an FDA 510(k) premarket notification submitted by Direx Systems Corp. for the device "TRIPTER X-1 COMPACT". The FDA issued a decision of Substantially Equivalent on April 28, 2004. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Direx Systems Corp. has at least 10 other 510(k) clearances on record.