EHL Probe
The SCDG-AS, SCDG-BS and SCDG-CS EHL probes deliver energy for fragmentation of stones in the bile duct. They are sterile, single-use accessories for the Potent Medical TCS-B3-II…
The SCDG-AS, SCDG-BS and SCDG-CS EHL probes deliver energy for fragmentation of stones in the bile duct. They are sterile, single-use accessories for the Potent Medical TCS-B3-II electrohydraulic lithotripter.
Electrical pulses travel from the separate generator through the probe. At the treatment end, the pulses generate hydraulic shock waves in a saline medium to fragment the biliary stones. A dedicated connection links each probe with the compatible lithotripter.
Probe Construction
The probe contains conductive wiring and polymer components. Its materials include stainless steel, polycarbonate, silver-plated copper wire, PTFE, FEP, polyimide and PFA. The probes are sterilized using ethylene oxide and are intended for prescription use with the specified generator.
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) | K243032 |
| Record published | 2025-06-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCDG – CS | In distribution | |
| SCDG – AS | In distribution | |
| SCDG – BS | 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.