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510(k) K201074

Delta III Lithotripter by Dornier Medtech America, Inc. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2020
Date Received
April 22, 2020
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 Dornier Medtech America, Inc.

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  • K201815 — Dornier MAGELLAN Ureteral Access Sheath (November 20, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
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  • K191187 — Dornier MINNOW Ureteral Catheter (September 18, 2019)

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)
  • 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)
  • K131817 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (September 26, 2014)