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510(k) K102169

CYBERWAND LITHOTRIPTER by Cybersonics, Inc. — Product Code FFK

K102169 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "CYBERWAND LITHOTRIPTER". The FDA issued a decision of Substantially Equivalent on August 30, 2010. 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
August 30, 2010
Date Received
August 2, 2010
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

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)
  • K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (June 5, 2012)
  • 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

  • K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) (March 21, 2025)
  • K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (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)

FDA data resources