# K042561: Twinheads TH-103 Extracorporeal Shock Wave Lithotripter

- Pathway: 510(k) (Special)
- Applicant: Fmd, LLC
- Decided: Oct 12, 2004 after 21 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: 2 generations back to K003529 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter, Fmd, LLC (2003) Summary page 1.

## Indications for use
The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

Source page: https://510kreport.com/device/K042561
Methodology: https://510kreport.com/methodology