Cyberwand Sterile Pads, Model: CW-RBPBX
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072422 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 Sterile Pads are sterile pads designed for use with the Cyberwand device. These pads are part of an electro-hydraulic lithotriptor system used in medical procedures.
The sterile pads are supplied in a single-use format and are regulated under FDA 510K authorization with product code FFK. They are intended for use in gastroenterology and urology procedures and are manufactured by Cybersonics Inc.
Frequently asked questions
What are Cyberwand Sterile Pads used for?
The Cyberwand Sterile Pads are designed for use with the Cyberwand device as part of an electro-hydraulic lithotriptor system. They are specifically intended for medical procedures in gastroenterology and urology.
How are the Cyberwand Sterile Pads supplied?
The sterile pads are supplied in a single-use format, ensuring sterility for each procedure. They are manufactured by Cybersonics Inc. and come ready for immediate use in medical settings.
What is the regulatory status of the Cyberwand Sterile Pads?
The Cyberwand Sterile Pads are regulated under FDA 510K authorization with product code FFK. They have been determined to be substantially equivalent to predicate devices in the gastroenterology and urology fields.
Are there different models or sizes available for the Cyberwand Sterile Pads?
The specific model referenced is CW-RBPBX. While the data doesn't indicate multiple sizes, this model is designed to work specifically with the Cyberwand electro-hydraulic lithotriptor system.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072422 | Class II | Active |
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Manufacturer
- Manufacturer
- Cybersonics Inc
- FDA Applicant
- Cybersonics, Inc.
Sources (1)
- FDA 510(k) K072422 24 fields · synced Sep 21, 2026