# K974796: Lithospec (TM) Intracorporeal Lithotripter

- Pathway: 510(k) (Traditional)
- Applicant: Medispec, Ltd.
- Decided: Mar 12, 1998 after 80 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- 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 K863642 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951531: Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1995) Summary page 2.
- K963285: Ems Swiss Lithoclast Lithotripter, Electro Medical Systems SA (1997) Summary page 2.

## Indications for use
The LITHOSPEC™ Intracorporeal Lithotripter is intended to be used during urological procedures to crush and remove bladder, ureteral and renal stones.

Source page: https://510kreport.com/device/K974796
Methodology: https://510kreport.com/methodology