# K042427: Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter

- Pathway: 510(k) (Special)
- Applicant: Genemed, Inc.
- Decided: Dec 3, 2004 after 86 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the non-invasive fragmentation of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.

Source page: https://510kreport.com/device/K042427
Methodology: https://510kreport.com/methodology