Cybersonics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ShockPulse-SE Lithotripsy System, Shock Pulse-SE Lithotripsy System CYBERWAND II, CYBERWAND STERILE PROBE SET
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cybersonics, Inc. Gastroenterology & Urology ✕
7 devices
Cleared
Aug 21, 2017
ShockPulse-SE Lithotripsy System
Gastroenterology & Urology
138d
Cleared
Nov 13, 2014
Shock Pulse-SE Lithotripsy System CYBERWAND II
Gastroenterology & Urology
76d
Cleared
Nov 26, 2013
CYBERWAND STERILE PROBE SET
Gastroenterology & Urology
81d
Cleared
Jun 05, 2012
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
Gastroenterology & Urology
125d
Cleared
Aug 30, 2010
CYBERWAND LITHOTRIPTER
Gastroenterology & Urology
28d
Cleared
Oct 24, 2007
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
Gastroenterology & Urology
57d
Cleared
Dec 20, 2005
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
Gastroenterology & Urology
137d