# K230893: Swiss LthoClast Trilogy

- Pathway: 510(k) (Traditional)
- Applicant: E.M.S Electro Medical Systems S.A
- Decided: Oct 23, 2023 after 206 days
- Product code: FEO (Lithotriptor, Ultrasonic)
- 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: 8 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)
- K191124: Swiss LithoClast Trilogy, E.M.S Electro Medical Systems S.A (2019) Summary page 4.

## Indications for use
The Swiss LithoClast® Trilogy is indicated for fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

Source page: https://510kreport.com/device/K230893
Methodology: https://510kreport.com/methodology