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510(k) K010900

STS-T LITHOTRIPTER, MODEL STS-T by Medstone Intl., Inc. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2001
Date Received
March 26, 2001
Clearance Type
Special
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 Medstone Intl., Inc.

  • K013620 — MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (January 22, 2002)
  • K905278 — STS(TM) FLUOROSCOPIC IMAGING MODULE (February 4, 1991)

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)