# K120303: Cyberwand Dual Action Ultrasonic Lithotripsy System

- Pathway: 510(k) (Abbreviated)
- Applicant: Cybersonics, Inc.
- Decided: Jun 5, 2012 after 125 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K863642 (1986). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter, Cybersonics, Inc. (2005) Summary page 1.
- K102169: Cyberwand Lithotripter, Cybersonics, Inc. (2010) Summary page 2.

## Most influential descendants
- K142428: Shock Pulse-SE Lithotripsy System CYBERWAND II (2014), 1 descendant of its own
- K171024: ShockPulse-SE Lithotripsy System (2017), 0 descendants of its own
- K132795: Cyberwand Sterile Probe Set (2013), 0 descendants of its own

## Indications for use
The Cyberand Dual Action Ultrasonic Lithotripsy System is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter and bladder.

Source page: https://510kreport.com/device/K120303
Methodology: https://510kreport.com/methodology