# K142428: Shock Pulse-SE Lithotripsy System CYBERWAND II

- Pathway: 510(k) (Traditional)
- Applicant: Cybersonics, Inc.
- Decided: Nov 13, 2014 after 76 days
- Product code: FEO (Lithotriptor, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K863642 (1986). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120303: Cyberwand Dual Action Ultrasonic Lithotripsy System, Cybersonics, Inc. (2012) Summary page 5.

## Most influential descendants
- K171024: ShockPulse-SE Lithotripsy System (2017), 0 descendants of its own

## Recalls of this device
- Apr 23, 2020 · Class II · Z-2197-2020: A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

## Indications for use
The ShockPulse-SE 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/K142428
Methodology: https://510kreport.com/methodology