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510(k) K092033

VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR by Elmed USA — Product Code FFK

K092033 is an FDA 510(k) premarket notification submitted by Elmed USA for the device "VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR". The FDA issued a decision of Substantially Equivalent on April 30, 2010. The device falls under product code FFK (Lithotriptor, Electro-Hydraulic), a Class II device regulated under 21 CFR 876.4480.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
July 6, 2009
Clearance Type
Traditional
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

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  • 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