CyberWand USL Ultrasonic Lithotripsy System
CyberWand USL is an ultrasonic lithotripsy system for fragmenting urinary stones in the kidney, ureter and bladder. It combines an electrical generator with ultrasonic transducers and a…
CyberWand USL is an ultrasonic lithotripsy system for fragmenting urinary stones in the kidney, ureter and bladder. It combines an electrical generator with ultrasonic transducers and a dual probe that carries vibration to the stone.
Piezoelectric elements in the handpiece are driven by the generator at approximately 20.4 to 22.2 kilohertz. The resulting longitudinal waves travel along the probe to fragment the stone. Hollow transducer probes also permit suction during fragmentation.
System Components
The system includes a footswitch, power cord, wrench and cleaning stylet. Disposable probe sets are supplied separately in sterile or non-sterile form.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Cybersonics, Inc., United States |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| 510(k) | K120303 |
| Record published | 2016-05-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CW-USLSA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lithoclast | E.M.S. Electro Medical Systems S.A. | 73 |
| Calcusplit | Karl Storz GmbH & Co. KG | 22 |
| Riwolith | Richard Wolf Gmbh | 14 |
| Lithotriptor, Electro-Hydraulic | Karl Storz GmbH & Co. KG | 12 |
| US-Litho | Richard Wolf Gmbh | 11 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 11 |
| Lithotriptor, Electro-Hydraulic | Richard Wolf Gmbh | 9 |
| EHL-Probe | Walz Elektronik Gmbh | 8 |
| Autolith Touch | Northgate Technologies Inc. | 7 |
| StoneBreaker | Cook Incorporated | 7 |
| Swiss LithoClast Select | E.M.S. Electro Medical Systems S.A. | 5 |
| Rigid Pneumatic Probe | Boston Scientific Corporation | 5 |
Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132795 | 2013-11-26 |
| K120303 | 2012-06-05 |
| K102169 | 2010-08-30 |
| K072422 | 2007-10-24 |
| K052135 | 2005-12-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.