FDA 510(k) Applications for Medical Device Product Code "FFK"
(Lithotriptor, Electro-Hydraulic)

FDA 510(k) Number Applicant Device Name Decision Date
K973788 BOSTON SCIENTIFIC CORP. MICROVASIVE LIPTHOTRIPSY PROBES 01/21/1998
K002084 BOSTON SCIENTIFIC CORP. MICROVASIVE LITHOTRIPTOR FLEXPROBE II 07/19/2000
K980492 CIRCON ACMI AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) 11/17/1998
K011848 CIRCON VIDEO CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE 09/11/2001
K052135 CYBERSONICS, INC. CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER 12/20/2005
K120303 CYBERSONICS, INC. CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM 06/05/2012
K102169 CYBERSONICS, INC. CYBERWAND LITHOTRIPTER 08/30/2010
K072422 CYBERSONICS, INC. CYBERWAND STERILE PADS, MODEL: CW-RBPBX 10/24/2007
K132795 CYBERSONICS, INC. CYBERWAND STERILE PROBE SET 11/26/2013
K963285 ELECTRO MEDICAL SYSTEMS SA EMS SWISS LITHOCLAST LITHOTRIPTER 02/13/1997
K012445 ELECTRO MEDICAL SYSTEMS SA EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) 08/24/2001
K992251 ELECTRO MEDICAL SYSTEMS SA SWISS LITHOCLAST MULTIPURPOSE PROBE 07/27/1999
K092033 ELMED USA VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR 04/30/2010
K123038 EMS ELECTRO MEDICAL SYSTEMS SA SWISS LITHOBREAKER 01/16/2013
K191124 EMS Electro Medical Systems SA Swiss LithoClast Trilogy 05/29/2019
K992114 KARL STORZ ENDOSCOPY KSEA CALCUSPLIT 08/18/1999
K981233 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA CALCUSPLIT 06/15/1998
K111058 MED-SONICS CORP URETRON MODEL URT 03/30/2012
K160198 Med-Sonics Corp UreTron MultiProbe Lithotripter System 02/23/2016
K162119 MED-SONICS CORP. UreTron PF Series Probe 08/29/2016
K974164 MEDICAL DEVICE CONSULTANTS, INC. SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE 12/18/1997
K974796 MEDISPEC, LTD. LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER 03/12/1998
K130368 NORTHGATE TECHNOLOGIES INC. AUTOLITH TOUCH; URO TOUCH 11/15/2013
K202813 Northgate Technologies Inc. URO-TOUCH 9 French Probe 06/14/2021
K990341 NORTHGATE TECHNOLOGIES, INC. ELECTRO MECHANICAL LITHOTRIPTOR 07/14/1999
K011065 RICHARD WOLF MEDICAL INSTRUMENTS CORP. INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) 05/09/2001
K011911 RICHARD WOLF MEDICAL INSTRUMENTS CORP. SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX 09/17/2001
K062475 THE LARYNGEAL MASK CO.,LTD. LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM 05/09/2007
K230488 Walz Elektronik GmbH EL27-Compact; Sterile EHL-Probes 08/31/2023


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