# K130729: Extra Corporeal Shockwave Lithotripter

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech Systems
- Decided: May 14, 2013 after 57 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K801623 (1980). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121656: Gemini Lithotripter, Dornier Medtech America, Inc. (2012) Summary page 1.
- K122768: Genesis, Dornier Medtech America, Inc. (2013) Summary page 1.

## Indications for use
The Gemini FPD is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Source page: https://510kreport.com/device/K130729
Methodology: https://510kreport.com/methodology