# K120769: Modulth SLK

- Pathway: 510(k) (Special)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 12, 2012 after 90 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: 1 generation back to K011700 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011700: Modulith SLK Lithotripter, Karl Storz Endoscopy (2002) Summary page 1.

## Most influential descendants
- K213772: LM-9300 Plus Lithotripter (2023), 0 descendants of its own

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

Source page: https://510kreport.com/device/K120769
Methodology: https://510kreport.com/methodology