Swiss LithoClast Select
Swiss LithoClast Ultra Console Upgrade Customer Owned
1manufacturer
5catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this 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 | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K012445 |
| Record published | 2017-02-13 |
| Record revised | 2024-10-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FT-148U | In distribution | |
| FT-148UR | In distribution | |
| FT-148UH | In distribution | |
| FT-196W | Withdrawn | |
| FT-196WR | Withdrawn |
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 |
| Rigid Pneumatic Probe | Boston Scientific Corporation | 5 |
| Ultrasound Probe | Boston Scientific Corporation | 4 |
Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191124 | 2019-05-29 |
| K123038 | 2013-01-16 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | 510(k) number | 2009-09-17 | Not classified | Other | The label incorrectly reads “compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)” instead of bearing the correct statement “compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170.” | 173 | 2010-10-08 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2005-03-16 | Not classified | Other | Handpiece may become dislodged causing cable damage and possible electric shock. | 160 units | 2016-02-02 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2003-10-03 | Not classified | Other | Failure of foot pedal to activate device | 96 units | 2004-07-20 |
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.