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.”
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| 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 |
Top Applicants
- Northgate Technologies, Inc. — 11 clearances
- Cybersonics, Inc. — 5 clearances
- Northgate Research, Inc. — 5 clearances
- Electro Medical Systems SA — 4 clearances
- Richard Wolf Medical Instruments Corp. — 4 clearances
