# K052135: Cybersonics Cyberwand Dual Probe Lithotripter

- Pathway: 510(k) (Abbreviated)
- Applicant: Cybersonics, Inc.
- Decided: Dec 20, 2005 after 137 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- 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: 3 generations back to K863642 (1986). 7 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra), Electro Medical Systems SA (2001)
- K973251: Ksea Calcuson, KARL STORZ Endoscopy-America, Inc. (1998) Summary page 2.

## Most influential descendants
- K102169: Cyberwand Lithotripter (2010), 5 descendants of its own
- K120303: Cyberwand Dual Action Ultrasonic Lithotripsy System (2012), 3 descendants of its own
- 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

## Recalls of this device
- May 23, 2007 · Not classified · Z-1073-2007: Sterilization Instructions not adequate for sterilizing.

## Indications for use
The Cyberwand Dual Probe Lithotripter is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

Source page: https://510kreport.com/device/K052135
Methodology: https://510kreport.com/methodology