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510(k) K120303

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2012
Date Received
February 1, 2012
Clearance Type
Abbreviated
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

Other clearances by Cybersonics, Inc.

  • K171024 — ShockPulse-SE Lithotripsy System (August 21, 2017)
  • K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II (November 13, 2014)
  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K102169 — CYBERWAND LITHOTRIPTER (August 30, 2010)
  • K072422 — CYBERWAND STERILE PADS, MODEL: CW-RBPBX (October 24, 2007)
  • K052135 — CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER (December 20, 2005)

Other clearances for product code FFK

  • K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (March 21, 2025)
  • K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) (March 21, 2025)
  • K230488 — EL27-Compact; Sterile EHL-Probes (August 31, 2023)
  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K162119 — UreTron PF Series Probe (August 29, 2016)
  • K160198 — UreTron MultiProbe Lithotripter System (February 23, 2016)
  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K123038 — SWISS LITHOBREAKER (January 16, 2013)