510(k) K010900

STS-T LITHOTRIPTER, MODEL STS-T by Medstone Intl., Inc. — Product Code LNS

K010900 is an FDA 510(k) premarket notification submitted by Medstone Intl., Inc. for the device "STS-T LITHOTRIPTER, MODEL STS-T". The FDA issued a decision of Substantially Equivalent on April 5, 2001. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Medstone Intl., Inc. has at least 2 other 510(k) clearances on record.