# K062147: Integra SL

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Oct 20, 2006 after 85 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: 5 generations back to P840008 (1984). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053640: Integra, Direx Systems Corp. (2006) Summary page 1.
- K041582: Modification to Tripter X-1 Compact Duet, Direx Systems Corp. (2004) Summary page 1.

## Most influential descendants
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own
- K252913: Break Wave (2026), 1 descendant of its own
- K261086: Break Wave (2026), 0 descendants of its own

## Indications for use
Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter

Source page: https://510kreport.com/device/K062147
Methodology: https://510kreport.com/methodology