Product code FFK
- Device name
- Lithotriptor, Electro-Hydraulic
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.4480
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | 2023-08-31 |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | 2021-06-14 |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | 2019-05-29 |
| K162119 | UreTron PF Series Probe | Med-Sonics Corp. | 2016-08-29 |
| K160198 | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | 2016-02-23 |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | 2013-11-26 |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | 2013-11-15 |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | 2013-01-16 |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | 2012-06-05 |
| K111058 | URETRON MODEL URT | Med-Sonics Corp. | 2012-03-30 |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | 2010-08-30 |
| K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | 2010-04-30 |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | 2007-10-24 |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | 2007-05-09 |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | 2005-12-20 |
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | Richard Wolf Medical Instruments Corp. | 2001-09-17 |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Circon Video | 2001-09-11 |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Electro Medical Systems SA | 2001-08-24 |
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) | Richard Wolf Medical Instruments Corp. | 2001-05-09 |
| K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | Boston Scientific Corp | 2000-07-19 |
| K992114 | KSEA CALCUSPLIT | Karl Storz Endoscopy | 1999-08-18 |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Electro Medical Systems SA | 1999-07-27 |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | Northgate Technologies, Inc. | 1999-07-14 |
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | Circon Acmi | 1998-11-17 |
| K981233 | KSEA CALCUSPLIT | KARL STORZ Endoscopy-America, Inc. | 1998-06-15 |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | Medispec, Ltd. | 1998-03-12 |
| K973788 | MICROVASIVE LIPTHOTRIPSY PROBES | Boston Scientific Corp | 1998-01-21 |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | Medical Device Consultants, Inc. | 1997-12-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613353125929 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2024-09-03 |
| 07613353214159 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2023-11-22 |
| 07613353125912 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2019-11-15 |
| 07613353177096 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2019-10-07 |
| 07613353177089 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2019-10-07 |
| 07613353172855 | LithoClast | E.M.S. Electro Medical Systems S.A. | 2019-07-29 |
| 07613353156121 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-09-03 |
| 07613353156114 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-09-03 |
| 07613353162603 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353164027 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353164010 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162702 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162696 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162689 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162658 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162641 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162634 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162627 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162610 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162597 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162580 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162573 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162566 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353162559 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353157982 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-08-31 |
| 07613353123697 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 07613353133351 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 07613353133337 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 07613353126391 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |
| 07613353123758 | LITHOCLAST | E.M.S. Electro Medical Systems S.A. | 2018-03-12 |