# K040476: Storz Modulith, Model SLX-F2

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 26, 2004 after 184 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Storz Modulith® Lithotripter Model SLX: named in the summary without a submission number

## Most influential descendants
- K101482: EM-9000 (2011), 2 descendants of its own
- K072788: Storz Modulith Lithotripter SLX-F2-F180 (2007), 1 descendant of its own
- K251562: OTSCneo System Set (100.03n-14n, 100.27n-31n) (2025), 0 descendants of its own
- K201001: Modulith SLX-F2 (2021), 0 descendants of its own
- K131721: Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 (2014), 0 descendants of its own

## Indications for use
The Storz Medical MODULITH® Model SLX F2 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter..

Source page: https://510kreport.com/device/K040476
Methodology: https://510kreport.com/methodology