# P870015: Medstone 1050 Ectracorporeal Shock Wave Lithotript

- Pathway: PMA
- Applicant: Medstone Intl., Inc.
- Decided: Apr 15, 1988 after 368 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 11, 2004 · Not classified · Z-0884-04: Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the bea

Source page: https://510kreport.com/device/P870015
Methodology: https://510kreport.com/methodology