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 |
| K243032 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | 03/21/2025 |
| K242888 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Electrohydraulic Lithotriptor (TCS-B3-II) | 03/21/2025 |
| 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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