# K011700: Modulith SLK Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Aug 16, 2002 after 441 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 no predicate by number.

## Most influential descendants
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own
- K252913: Break Wave (2026), 1 descendant of its own
- K120769: Modulth SLK (2012), 1 descendant of its own
- K261086: Break Wave (2026), 0 descendants of its own
- K213772: LM-9300 Plus Lithotripter (2023), 0 descendants of its own

## Indications for use
Storz Modulith@Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.

Source page: https://510kreport.com/device/K011700
Methodology: https://510kreport.com/methodology