# K132795: Cyberwand Sterile Probe Set

- Pathway: 510(k) (Special)
- Applicant: Cybersonics, Inc.
- Decided: Nov 26, 2013 after 81 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: 6 generations back to K863642 (1986). 11 ancestors in all.
No later device cites it as a predicate yet.
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 1.
- K072422: Cyberwand Sterile Pads, Model: CW-Rbpbx, Cybersonics, Inc. (2007) Summary page 1.

## Indications for use
The CyberWand Sterile Probe Set is designed to be used only with the CyberWand Dual Action Ultrasonic Lithotripsy System for the fragmentation of urinary tract calculi in the kidneys, ureter, and bladder.

Source page: https://510kreport.com/device/K132795
Methodology: https://510kreport.com/methodology