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 |