510(k) K120303

CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM by Cybersonics, Inc. — Product Code FFK

K120303 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 5, 2012. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480. Cybersonics, Inc. has at least 6 other 510(k) clearances on record.