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510(k) K963285

EMS SWISS LITHOCLAST LITHOTRIPTER by Electro Medical Systems SA — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1997
Date Received
August 21, 1996
Clearance Type
Traditional
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 Electro Medical Systems SA

  • K022328 — EMS PIEZON MASTER 600 (August 13, 2002)
  • K022119 — EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE (July 25, 2002)
  • K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (August 24, 2001)
  • K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (October 4, 2000)
  • K991857 — AIRFLOW HANDY (October 7, 1999)
  • K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE (July 27, 1999)
  • K965203 — RADX SYSTEM (March 17, 1997)
  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K953026 — MINIPIEZON (August 28, 1995)
  • K951531 — SWISS LITHOCLAST LITHOTRIPTER (August 24, 1995)

Other clearances for product code FFK

  • K243032 — EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (March 21, 2025)
  • K242888 — Electrohydraulic Lithotriptor (TCS-B3-II) (March 21, 2025)
  • K230488 — EL27-Compact; Sterile EHL-Probes (August 31, 2023)
  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K162119 — UreTron PF Series Probe (August 29, 2016)
  • 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)