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510(k) K162119

UreTron PF Series Probe by Med-Sonics Corp. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2016
Date Received
August 1, 2016
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 Med-Sonics Corp.

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  • K111058 — URETRON MODEL URT (March 30, 2012)

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  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • 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)
  • K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM (June 5, 2012)