# K111058: Uretron Model Urt

- Pathway: 510(k) (Abbreviated)
- Applicant: Med-Sonics Corp.
- Decided: Mar 30, 2012 after 347 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.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102169: Cyberwand Lithotripter, Cybersonics, Inc. (2010) Summary page 1.
- K052135: Cybersonics Cyberwand Dual Probe Lithotripter, Cybersonics, Inc. (2005) Summary page 2.
- K012445: Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra), Electro Medical Systems SA (2001) Summary page 1.

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

Source page: https://510kreport.com/device/K111058
Methodology: https://510kreport.com/methodology