Shock Pulse-SE Lithotripsy System CYBERWAND II
FDA 510(k) K142428 · Cybersonics, Inc.
510(k) numberK142428
Submission
- Device name
- Shock Pulse-SE Lithotripsy System CYBERWAND II
- Applicant
- Cybersonics, Inc.
Erie, PA, US - Received
- August 29, 2014
- Decision date
- November 13, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEO – Lithotriptor, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FEO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230893 | Swiss LthoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 10/23/2023SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 08/30/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 01/10/2018SE |
| K171024 | ShockPulse-SE Lithotripsy SystemFEO · Traditional | Cybersonics, Inc. | 08/21/2017SE |
| K993046 | Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model LS-2000FEO · Traditional | Fibra Sonics, Inc. | 11/22/1999SE |
| K973251 | Ksea CalcusonFEO · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/22/1998SE |
| K920235 | Ultrasound Generator Modle 2270FEO · Traditional | Richard Wolf Medical Instruments Corp. | 12/07/1992SE |
| K873367 | Olympus Lus Ultrasonic LithotripterFEO · Traditional | Olympus Corp. | 11/30/1987SE |
More from Olympus Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K171024 | ShockPulse-SE Lithotripsy SystemFEO · Traditional | 08/21/2017SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | 11/26/2013SE |
| K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy SystemFFK · Abbreviated | 06/05/2012SE |
| 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 Shock Pulse-SE Lithotripsy System CYBERWAND II cleared by the FDA?
Shock Pulse-SE Lithotripsy System CYBERWAND II (K142428) received a 510(k) decision of Substantially Equivalent on November 13, 2014, 76 days after the submission was received.
What is the product code of K142428?
The FDA product code is FEO – Lithotriptor, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.