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510(k) K063504

ECONOLITH EM1000 by Medispec, Ltd. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2007
Date Received
November 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

Other clearances by Medispec, Ltd.

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  • K040461 — ECONOLITH E3000, MODEL 3000 (SW-6) (May 25, 2004)
  • K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER (March 12, 1998)

Other clearances for product code LNS

  • K252913 — Break Wave (January 12, 2026)
  • K242922 — Extracorporeal Shock Wave Lithotripter (U200) (June 18, 2025)
  • K221903 — Delta III Pro (February 22, 2023)
  • K213772 — LM-9300 Plus Lithotripter (January 19, 2023)
  • K201001 — Modulith SLX-F2 (March 30, 2021)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)