Cyberwand Dual Action Ultrasonic Lithotripsy System
FDA 510(k) K120303 · Cybersonics, Inc.
510(k) numberK120303
Submission
- Device name
- Cyberwand Dual Action Ultrasonic Lithotripsy System
- Applicant
- Cybersonics, Inc.
Erie, PA, US - Received
- February 1, 2012
- Decision date
- June 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K230488 | EL27-Compact; Sterile EHL-ProbesFFK · Traditional | Walz Elektronik GmbH | 08/31/2023SE |
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | Northgate Technologies, Inc. | 06/14/2021SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | E.M.S Electro Medical Systems S.A | 05/29/2019SE |
| K162119 | UreTron PF Series ProbeFFK · Special | Med-Sonics Corp. | 08/29/2016SE |
| K160198 | UreTron MultiProbe Lithotripter SystemFFK · Special | Med-Sonics Corp. | 02/23/2016SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | Cybersonics, Inc. | 11/26/2013SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | Northgate Technologies, Inc. | 11/15/2013SE |
| K123038 | Swiss LithobreakerFFK · Traditional | E.M.S Electro Medical Systems S.A | 01/16/2013SE |
More from E.M.S Electro Medical Systems S.A
| 510(k) | Device | Decision |
|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy SystemFEO · Traditional | 08/21/2017SE |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND IIFEO · Traditional | 11/13/2014SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | 11/26/2013SE |
| K102169 | Cyberwand LithotripterFFK · Special | 08/30/2010SE |
| K072422 | Cyberwand Sterile Pads, Model: Cw-RbpbxFFK · Special | 10/24/2007SE |
| K052135 | Cybersonics Cyberwand Dual Probe LithotripterFFK · Abbreviated | 12/20/2005SE |
Questions and answers
When was Cyberwand Dual Action Ultrasonic Lithotripsy System cleared by the FDA?
Cyberwand Dual Action Ultrasonic Lithotripsy System (K120303) received a 510(k) decision of Substantially Equivalent on June 5, 2012, 125 days after the submission was received.
What is the product code of K120303?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.