# K201001: Modulith SLX-F2

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy America
- Decided: Mar 30, 2021 after 348 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: 5 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)
- K072788: Storz Modulith Lithotripter SLX-F2-F180, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 4.
- K142561: LM-9300 ELMA Lithotripter, Lite-Med, Inc. (2015) Summary page 4.

## Indications for use
The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.

Source page: https://510kreport.com/device/K201001
Methodology: https://510kreport.com/methodology