510(k) K072422

CYBERWAND STERILE PADS, MODEL: CW-RBPBX by Cybersonics, Inc. — Product Code FFK

K072422 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "CYBERWAND STERILE PADS, MODEL: CW-RBPBX". The FDA issued a decision of Substantially Equivalent on October 24, 2007. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2007
Date Received
August 28, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type