Identity
- Trade Name
- ShockPulse FDA UDI
- Generic Name
- Pneumatic/ultrasonic lithotripsy system FDA UDI
- Device Name
- SHOCKPULSE LITHOTRIPSY TRANSDUCER FDA UDI
- Model / Reference
- SPL-T FDA UDI
- Description
- SHOCKPULSE LITHOTRIPSY TRANSDUCER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925043831 FDA UDI
- 510(k) Number
- K171024 FDA UDI
- FDA Product Code
- FEO FDA UDI
- GMDN Term
- Pneumatic/ultrasonic 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
Ethylene Oxide FDA UDI
Category: Pneumatic/ultrasonic lithotripsy system
ShockPulse by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic/ultrasonic lithotripsy system.
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- CyberWand USL Ultrasonic Lithotripsy System — CYBERSONICS INC · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LithoClast — E.M.S. Electro Medical Systems S.A. · Class II
Cleared under the same submission
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI c37692e4-41e7-4f7d-96c5-86bd3e829936 34 fields · synced May 30, 2026