# K033335: Lithostar Modularis with Shockwave System Cplus

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 25, 2003 after 40 days
- Product code: MMZ (Table, Cystometric, Electric)
- Device class: 2
- Regulation: 21 CFR 876.4890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P870018 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P870018: Lithostar, Siemens Corp. (1988) Summary page 1.

## Recalls of this device
- Oct 1, 2006 · Not classified · Z-0168-2007: Potential pinch point with the patient table

## Indications for use
LITHOSTAR Modularis with Shockwave System Cplus is a urologic procedures system which can be used for a wide range of applications. It is a transportable system. The system is capable of both diagnostic and therapeutic procedures of urolithiasis in the kidney and upper ureter. The primary use of this device is for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvis stones, and upper ureteral stones by extracorporeal shock wave lithotripsy (ESWL). In addition to ESWL use, the unit is designed for patient placement in positions which facilitate urological and diagnostic procedures.

Source page: https://510kreport.com/device/K033335
Methodology: https://510kreport.com/methodology