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510(k) K171024

ShockPulse-SE Lithotripsy System by Cybersonics, Inc. — Product Code FEO

K171024 is an FDA 510(k) premarket notification submitted by Cybersonics, Inc. for the device "ShockPulse-SE Lithotripsy System". The FDA issued a decision of Substantially Equivalent on August 21, 2017. 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
August 21, 2017
Date Received
April 5, 2017
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.

  • 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)
  • 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)
  • K142428 — Shock Pulse-SE Lithotripsy System CYBERWAND II (November 13, 2014)
  • 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