510(k) K041582

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

K041582 is an FDA 510(k) premarket notification submitted by Direx Systems Corp. for the device "MODIFICATION TO TRIPTER X-1 COMPACT DUET". The FDA issued a decision of Substantially Equivalent on July 7, 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.