Identity
- Trade Name
- ShockPulse FDA UDI
- Generic Name
- Pneumatic/ultrasonic lithotripsy system FDA UDI
- Device Name
- SHOCKPULSE LITHOTRIPSY CLEANING STYLET (SMALL) FDA UDI
- Model / Reference
- SPL-CSS FDA UDI
- Description
- SHOCKPULSE LITHOTRIPSY CLEANING STYLET (SMALL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925043688 FDA UDI
- 510(k) Number
- K142428 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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.
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- LithoClast — E.M.S. Electro Medical Systems S.A. · Class II
- LITHOCLAST — E.M.S. Electro Medical Systems S.A. · Class II
- CyberWand USL Generator — CYBERSONICS INC · Class II
- CyberWand USL Power Cord — CYBERSONICS INC · Class II
- 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
K142428 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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 47fbca9c-be5c-48a7-841b-4c821b030e92 34 fields · synced Jun 6, 2026