CyberWand USL Generator
Catalogue number CW-USLG, listed by Cybersonics, Inc., United States, under Lithotriptor, Electro-Hydraulic. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
5510(k) clearances naming this product code
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-USLG | 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.