# K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1

- Pathway: 510(k) (Traditional)
- Applicant: Comed Medical Systems Co., Ltd.
- Decided: Jul 22, 2014 after 405 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: 4 generations back to P970019 (1997). 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)
- K101482: EM-9000, Elite Medical, Inc. (2011) Summary page 1.
- K103217: Lite-Med LM-9200 Elma, Lite-Med, Inc. (2011) Summary page 1.

## Indications for use
The GEMISS UROCAMP ASADAL-MI 1, Extracorporeal Shockwave Lithotripler is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

Source page: https://510kreport.com/device/K131721
Methodology: https://510kreport.com/methodology