Instruments for functional explorations and therapeutic interventionsEndoscopic and minimally invasive surgery instrumentsEndoscopic lithotripsy instruments
Endoscopic lithotripsy instruments - consumables
EMDN code Z12020385
Manufacturers registered in Europe (EUDAMED) 1
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Walz Elektronik FDA | Germany |
|
IIa MDR | Website info@walz-el.de EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 17
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| E.M.S Electro Medical Systems S.A Present in Europe in other categories | United States | LITHOCLAST Swiss LithoClast Select SWISS DolorClast | K191124 (2019) |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | Calcusplit n.a. | registered |
| Northgate Technologies, Inc. | United States | Autolith Touch Lithotripsy Probe 1.9FR 375cm DS Lithotripsy Probe 1.9FR 120cm Lithotripsy Probe 9FR 54cm Lithotripsy Probe 1.9FR 375cm Lithotripsy Probe 1.9FR 250cm | K202813 (2021) |
| Ultratellege USA Co., Ltd. | United States | UreTron Flexible Sterile Probe UreTron Semi Rigid Sterile Probe 1.5 x 480 mm UreTron Rigid Sterile Probe 3.5 x 370 mm UreTron Rigid Sterile Probe 3.1 x 370mm UreTron Flexible Sterile Probe 0.8 x 600 mm UreTron Rigid Hand Piece | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | Rigid Pneumatic Probe Ultrasound Probe Flexible Probe | K002084 (2000) |
| Cybersonics, Inc. | United States | Cyberwand USL Wrench CyberWand Probe Set CyberWand USL Power Cord CyberWand USL Foot Switch CyberWand USL NoseCone Kit CyberWand USL Generator | K132795 (2013) |
| Cook, Inc. | United States | StoneBreaker | registered |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Present in Europe in other categories | China | EHL Probe Electrohydraulic Lithotriptor | K242888 (2025) |
| Richard Wolf GmbH Present in Europe in other categories | Germany | – | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI | registered |
| Medispec, Ltd. | United States | Lithospec | K974796 (1998) |
| Electro Medical Systems SA | United States | – | K012445 (2001) |
| Medsonics | United States | – | K162119 (2016) |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Promepla Present in Europe in other categories | Monaco | – | registered |
| STERIPAC GMBH | Germany | – | registered |
| SunMed Group Holdings, LLC dba AirLife | United States | – | registered |
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Related categories
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- Parent category : Endoscopic lithotripsy instruments8 manufacturers