# K131817: Extracorporeal Shock Wave Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Osmunda Medical Device Consulting Co., Ltd.
- Decided: Sep 26, 2014 after 463 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. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- P840008/S06: Unnamed device. Number could not be read
- K103217: Lite-Med LM-9200 Elma, Lite-Med, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K131817
Methodology: https://510kreport.com/methodology