Electrohydraulic Lithotriptor
The Electrohydraulic Lithotriptor fragments stones in the bile duct using a compatible disposable Potent Medical EHL probe introduced through an endoscope. The tabletop unit generates…
The Electrohydraulic Lithotriptor fragments stones in the bile duct using a compatible disposable Potent Medical EHL probe introduced through an endoscope. The tabletop unit generates high-voltage pulses that travel to the probe, where they create hydraulic shock waves in saline.
A footswitch controls pulse delivery, with single-pulse and continuous-pulse modes available. The resulting shock waves break biliary stones into smaller pieces for subsequent passage or endoscopic removal.
Separate Probe
The system includes the generator, footswitch and power cable. Disposable EHL probes are purchased separately and must be the compatible Potent Medical probes intended for the system.
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 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., China |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Manufacturer |
| 510(k) | K242888 |
| Record published | 2025-06-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCS-B3-II | 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 |
|---|---|
| K242888 | 2025-03-21 |
| K243032 | 2025-03-21 |
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.