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510(k) K142428

Shock Pulse-SE Lithotripsy System CYBERWAND II by Cybersonics, Inc. — Product Code FEO

K142428 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "Shock Pulse-SE Lithotripsy System CYBERWAND II". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code FEO (Lithotriptor, Ultrasonic), 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
November 13, 2014
Date Received
August 29, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Ultrasonic
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)
  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (June 5, 2012)
  • 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 FEO

  • K230893 — Swiss LthoClast Trilogy (October 23, 2023)
  • K182490 — Swiss LithoClast Trilogy (October 9, 2018)
  • K181997 — Swiss LithoClast Trilogy (August 30, 2018)
  • K181364 — Swiss LithoClast Trilogy (June 20, 2018)
  • K173234 — Swiss LithoClast Trilogy (January 10, 2018)
  • K171024 — ShockPulse-SE Lithotripsy System (August 21, 2017)
  • K993046 — FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 (November 22, 1999)
  • K973251 — KSEA CALCUSON (June 22, 1998)
  • K920235 — ULTRASOUND GENERATOR MODLE 2270 (December 7, 1992)
  • K873367 — OLYMPUS LUS ULTRASONIC LITHOTRIPTER (November 30, 1987)

FDA data resources