510(k) K052135

CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER by Cybersonics, Inc. — Product Code FFK

K052135 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on December 20, 2005. 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.