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510(k) K992114

KSEA CALCUSPLIT by Karl Storz Endoscopy — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1999
Date Received
June 22, 1999
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 Karl Storz Endoscopy

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  • K030009 — KSEA POWERSHAVER SYSTEM S2 (April 2, 2003)
  • K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR (February 21, 2003)
  • K023187 — KSEA SPINOSCOPE (December 2, 2002)
  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
  • K021776 — KSEA QUADRO SWITCH (August 15, 2002)
  • K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (February 26, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)

Other clearances for product code FFK

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  • 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)