CyberWand Dual Action Ultrasonic Lithotripsy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120303 FDA 510(k)
- FDA Product Code
- FFK 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 CyberWand Dual Action Ultrasonic Lithotripsy System is an electro-hydraulic lithotriptor, designed to fragment urinary calculi (stones) in the kidney, bladder, or ureter. It combines ultrasonic and shockwave energy through a single probe to efficiently break down stones, reducing procedural time while minimizing tissue trauma.
This system is intended for use in urology and gastroenterology settings, supplied as a reusable medical device. It operates under FDA 510(k) clearance (K120303) and adheres to regulatory classification Class II (876.4480). The device requires proper sterilization and maintenance per manufacturer guidelines, with no specific MRI safety restrictions noted in the data.
Frequently asked questions
What clinical specialties is the CyberWand Dual Action Ultrasonic Lithotripsy System primarily used in, and why is this relevant for my practice?
The CyberWand is designed for use in urology and gastroenterology settings, as indicated by its regulatory submissions to the Gastroenterology and Urology advisory committees. This dual-specialty focus reflects its application in breaking down urinary calculi (stones) in the kidney, bladder, or ureter—common concerns in both specialties. If your practice involves stone removal or fragmentation procedures, this system aligns with established protocols in those fields.
Is the CyberWand Dual Action Ultrasonic Lithotripsy System single-use or reusable, and what does that mean for my facility’s workflow?
The CyberWand is classified as a reusable medical device, meaning it is intended for multiple uses after proper sterilization and maintenance. This requires your facility to follow manufacturer guidelines for cleaning, disinfection, and sterilization to ensure safety and functionality between procedures. Reusability can reduce costs but also demands dedicated resources for upkeep.
What types of stones does the CyberWand Dual Action Ultrasonic Lithotripsy System target, and how does its dual-energy approach benefit patients?
The CyberWand is specifically designed to fragment urinary calculi (stones) in the kidney, bladder, or ureter. Its combined ultrasonic and shockwave energy through a single probe is intended to efficiently break down stones while minimizing tissue trauma. This dual-action approach may reduce procedural time compared to traditional methods, potentially improving patient comfort and outcomes.
Are there any special storage or handling requirements for the CyberWand Dual Action Ultrasonic Lithotripsy System, particularly regarding its reusable nature?
Since the CyberWand is reusable, it must be stored in a clean, dry environment and handled according to manufacturer guidelines to prevent contamination. Proper sterilization between uses is critical, as outlined in the device’s maintenance protocols. Additionally, ensure the system is protected from physical damage or exposure to liquids, as this could compromise its performance or safety for subsequent procedures.
How do I verify the regulatory compliance of the CyberWand Dual Action Ultrasonic Lithotripsy System before purchasing or using it?
The CyberWand holds FDA 510(k) clearance (K120303) and is classified under Class II (876.4480), indicating it meets U.S. regulatory standards for electro-hydraulic lithotriptors. The device’s registration numbers (e.g., 3006546082) and product code (FFK) can be cross-referenced with the FDA’s database to confirm its compliance status. Always verify the specific lot or batch against manufacturer documentation to ensure it aligns with approved specifications.
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: Olympus Announces Intention to Acquire Lithotripsy Systems from ..., Olympus Announces Intention to Acquire Lithotripsy Systems from ..., Lithotripsy | Olympus America | Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120303 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybersonics Inc
- FDA Applicant
- Cybersonics, Inc.
Sources (1)
- FDA 510(k) K120303 24 fields · synced Sep 19, 2026