510(k) K132795

CYBERWAND STERILE PROBE SET by Cybersonics, Inc. — Product Code FFK

K132795 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "CYBERWAND STERILE PROBE SET". The FDA issued a decision of Substantially Equivalent on November 26, 2013. 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.