# DEN230082: Stone Clear (SC-LP9-01)

- Pathway: De Novo (Direct)
- Applicant: Sonomotion, Inc.
- Decided: Oct 30, 2024 after 328 days
- Product code: QNA (Ultrasonic Urinary Stone Propulsion Device)
- Device class: 2
- Regulation: 21 CFR 876.4690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K262200: Stone Clear (BWSC-LP9-02) (2026), 0 descendants of its own

## Indications for use
The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.

Source page: https://510kreport.com/device/DEN230082
Methodology: https://510kreport.com/methodology