Identity
- Trade Name
- EL27-Compact FDA UDI
- Generic Name
- Electrohydraulic lithotripsy system FDA UDI
- Device Name
- Electrohydraulic Lithotripter FDA UDI
- Model / Reference
- EL27C115VEHL FDA UDI
- Description
- Electrohydraulic Lithotripter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260667540011 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrohydraulic lithotripsy system
EL27-Compact by Walz Elektronik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrohydraulic lithotripsy system.
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- 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 6f4d352d-2479-49a7-9d2d-66333dad0193 34 fields · synced Jun 1, 2026