Identity
- Trade Name
- EHL-Probe FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Device Name
- Diamaeter of 4,5 Fr. with a length of 3 meter. FDA UDI
- Model / Reference
- P453000FST FDA UDI
- Description
- Diamaeter of 4,5 Fr. with a length of 3 meter. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260667540196 FDA UDI
- 510(k) Number
- K230488 FDA UDI
- FDA Product Code
- FFK FDA UDI
- GMDN Term
- Electrohydraulic lithotripsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4480 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrohydraulic lithotripsy system
EHL-Probe by Walz Elektronik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrohydraulic lithotripsy system.
- Autolith Uro-Touch — Northgate Technologies Inc. · Class II
- Electrohydraulic Lithotriptor — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
- Econolith E3000 — Medispec, Ltd. · Class II
- CyberWand — Gyrus Acmi, Inc. · Class II
- Autolith Touch — Northgate Technologies Inc. · Class II
- EHL Probe — Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · Class II
- CYBERWAND — Gyrus Acmi, Inc. · Class II
- Autolith 115V — Northgate Technologies Inc. · Class II
Cleared under the same submission
K230488 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Walz Elektronik GmbH
Sources (1)
- FDA UDI b003415f-6ef7-4daa-9fc3-d3284cd6c1f5 34 fields · synced Jun 1, 2026