FFK · Lithotriptor, Electro-Hydraulic
Gastroenterology, Urology · 21 CFR 876.4480 · Class 2
Overview
| Product Code | FFK |
|---|---|
| Device Name | Lithotriptor, Electro-Hydraulic |
| Regulation | 21 CFR 876.4480 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.
Classification Rationale
Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
Cleared Devices (61)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 | SESE |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Mar 21, 2025 | SESE |
| K230488 | EL27-Compact; Sterile EHL-Probes | Walz Elektronik GmbH | Aug 31, 2023 | SESE |
| K202813 | URO-TOUCH 9 French Probe | Northgate Technologies, Inc. | Jun 14, 2021 | SESE |
| K191124 | Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A | May 29, 2019 | SESE |
| K162119 | UreTron PF Series Probe | Med-Sonics Corp. | Aug 29, 2016 | SESE |
| K160198 | UreTron MultiProbe Lithotripter System | Med-Sonics Corp. | Feb 23, 2016 | SESE |
| K132795 | CYBERWAND STERILE PROBE SET | Cybersonics, Inc. | Nov 26, 2013 | SESE |
| K130368 | AUTOLITH TOUCH; URO TOUCH | Northgate Technologies, Inc. | Nov 15, 2013 | SESE |
| K123038 | SWISS LITHOBREAKER | E.M.S Electro Medical Systems S.A | Jan 16, 2013 | SESE |
| K120303 | CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM | Cybersonics, Inc. | Jun 5, 2012 | SESE |
| K111058 | URETRON MODEL URT | Med-Sonics Corp. | Mar 30, 2012 | SESE |
| K102169 | CYBERWAND LITHOTRIPTER | Cybersonics, Inc. | Aug 30, 2010 | SESE |
| K092033 | VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR | Elmed USA | Apr 30, 2010 | SESE |
| K072422 | CYBERWAND STERILE PADS, MODEL: CW-RBPBX | Cybersonics, Inc. | Oct 24, 2007 | SESE |
| K062475 | LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM | The Laryngeal Mask Co., Ltd. | May 9, 2007 | SESE |
| K052135 | CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER | Cybersonics, Inc. | Dec 20, 2005 | SESE |
| K011911 | SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX | Richard Wolf Medical Instruments Corp. | Sep 17, 2001 | SESE |
| K011848 | CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE | Circon Video | Sep 11, 2001 | SESE |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | Electro Medical Systems SA | Aug 24, 2001 | SESE |
| K011065 | INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) | Richard Wolf Medical Instruments Corp. | May 9, 2001 | SESE |
| K002084 | MICROVASIVE LITHOTRIPTOR FLEXPROBE II | Boston Scientific Corp | Jul 19, 2000 | SESE |
| K992114 | KSEA CALCUSPLIT | Karl Storz Endoscopy | Aug 18, 1999 | SESE |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | Electro Medical Systems SA | Jul 27, 1999 | SESE |
| K990341 | ELECTRO MECHANICAL LITHOTRIPTOR | Northgate Technologies, Inc. | Jul 14, 1999 | SESE |
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) | Circon Acmi | Nov 17, 1998 | SESE |
| K981233 | KSEA CALCUSPLIT | KARL STORZ Endoscopy-America, Inc. | Jun 15, 1998 | SESE |
| K974796 | LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER | Medispec, Ltd. | Mar 12, 1998 | SESE |
| K973788 | MICROVASIVE LIPTHOTRIPSY PROBES | Boston Scientific Corp | Jan 21, 1998 | SESE |
| K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | Medical Device Consultants, Inc. | Dec 18, 1997 | SESE |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | Feb 13, 1997 | SESE |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | Electro Medical Systems SA | Aug 24, 1995 | SESE |
| K944571 | PULSE GUARD 3FR ELECTRODE | Northgate Technologies, Inc. | Mar 17, 1995 | SESE |
| K931755 | RIWOLITH 2280 PROBES | Richard Wolf Medical Instruments Corp. | Apr 15, 1994 | SESE |
| K931779 | EHL PULSE GENERATOR | Psi Medical Products, Inc. | Feb 15, 1994 | SESE |
| K920410 | EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB | Psi Medical Products, Inc. | Feb 14, 1994 | SESE |
| K925396 | PULSE GUARD ELECTRODE | Northgate Technologies, Inc. | Jul 30, 1993 | SESE |
| K923822 | AUTOLITH-IEHL | Northgate Technologies, Inc. | Jan 28, 1993 | SESE |
| K914517 | SD-200IEHL(TM) | Northgate Technologies, Inc. | Jun 30, 1992 | SESE |
| K913487 | RIWOLITH 2280 | Richard Wolf Medical Instruments Corp. | Feb 5, 1992 | SESE |
| K914516 | 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | Jan 7, 1992 | SESE |
| K914515 | 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | Jan 7, 1992 | SESE |
| K914514 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | Jan 6, 1992 | SESE |
| K913955 | 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION | Northgate Technologies, Inc. | Nov 29, 1991 | SESE |
| K905553 | LITHOTRIPTOR SYSTEM MODEL 27080 | Karl Storz GmbH & Co. (Kst) | Jun 4, 1991 | SESE |
| K903337 | 1.9 FRENCH LITHOTRIPTER ELECTRODE | Northgate Research, Inc. | Nov 16, 1990 | SESE |
| K894704 | 2.5 FRENCH LITHOTRIPTOR ELECTRODE | Northgate Research, Inc. | Oct 18, 1989 | SESE |
| K895178 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | Oct 6, 1989 | SESE |
| K885255 | MDL-1 LASERTRIPTER(TM) | Candela Laser Corp. | Jun 1, 1989 | SESE |
| K890436 | TECHNOMED PULSOLITH LASER SYSTEM | Teknomed, Inc. | Mar 23, 1989 | SESE |
| K883189 | MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS | KARL STORZ Endoscopy-America, Inc. | Feb 13, 1989 | SESE |
| K880503 | MDL-1 LASERTRIPTER | Candela Laser Corp. | Jun 17, 1988 | SESE |
| K864904 | 3F ELECTRODE | Northgate Research, Inc. | Feb 10, 1987 | SESE |
| K863642 | CANDELA MODEL MDL-1 LASER LITHOTRIPTOR | Candela Corp. | Dec 3, 1986 | SESE |
| K852874 | 5F ELECTRODE(LITHOTRIPTOR) | Northgate Research, Inc. | Aug 21, 1985 | SESE |
| K834228 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | May 25, 1984 | SESE |
| K832566 | COAXIAL ELECTRODE #300A | K-Med, Inc. | Nov 28, 1983 | SESE |
| K830086 | 4.5 F LITHOTRIPTOR ELECTRODE | Monaghan Medical Corp. | Feb 9, 1983 | SESE |
| K822585 | LITHOTRIPTOR ELECTRODE 4.5F | Monaghan Medical Corp. | Sep 28, 1982 | SESE |
| K822644 | RIWOLITH 2135 | R. Wolf Medical Instruments Corp. | Sep 21, 1982 | SESE |
| K802322 | MODEL SD-1 DISINTEGRATOR | Northgate Research, Inc. | Nov 10, 1980 | SESE |
Top Applicants
- Northgate Technologies, Inc. — 11 clearances
- Northgate Research, Inc. — 5 clearances
- Cybersonics, Inc. — 5 clearances
- Richard Wolf Medical Instruments Corp. — 4 clearances
- Electro Medical Systems SA — 4 clearances
