Shock Pulse-Se Lithotripsy System Cyberwand Ii
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142428 FDA 510(k)
- FDA Product Code
- FEO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4480 FDA 510(k)
- Regulation Number
- 876.4480 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shock Pulse-Se Lithotripsy System Cyberwand Ii is a lithotriptor, ultrasonic device used for lithotripsy. It is designed to produce constant ultrasonic wave energy and intermittent shockwave energy via a single probe.
The device is supplied as a system and is intended for use in gastroenterology and urology. It has been cleared under the FDA 510k traditional submission with the clearance type being substantially equivalent. The device has a product code of FEO and is regulated under regulation number 876.4480.
Frequently asked questions
What is the Cyberwand II Lithotripsy System used for?
The Cyberwand II is used for lithotripsy, a medical procedure that uses shock waves to break up stones in the kidney, bladder, or ureters, and is intended for use in gastroenterology and urology.
How is the Cyberwand II supplied?
The Cyberwand II is supplied as a system, including a single probe that produces constant ultrasonic wave energy and intermittent shockwave energy.
What regulatory clearance does the Cyberwand II have?
The Cyberwand II has been cleared under the FDA 510k traditional submission, with a clearance type of substantially equivalent, and is regulated under regulation number 876.4480.
What is the product code for the Cyberwand II?
The product code for the Cyberwand II is FEO.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ShockPulse-SE | Olympus America | Medical, Shock Pulse-SE Lithotripsy System CYBERWAND II, ShockPulse-SE Lithotriptor - Olympus Medical Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142428 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybersonics Inc
- FDA Applicant
- Cybersonics, Inc.
Sources (1)
- FDA 510(k) K142428 24 fields · synced Sep 24, 2026