Home / 510(k) Clearances / K151298

510(k) K151298

Gemini XXP-HP by Dornier Medtech America — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2015
Date Received
May 15, 2015
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

  • K243820 — Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, I (January 31, 2025)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K221903 — Delta III Pro (February 22, 2023)
  • K213252 — Dornier Thulio (July 27, 2022)
  • K220871 — Nautilus (April 18, 2022)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K201815 — Dornier MAGELLAN Ureteral Access Sheath (November 20, 2020)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K190312 — Dornier Ureteral Stent (November 15, 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)
  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)
  • K131817 — EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (September 26, 2014)