QNA
- Product code
- QNA
- Device name
- Ultrasonic Urinary Stone Propulsion Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4690
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 2 (all years; only the last 3 years are listed here)
FDA classification definition
An ultrasonic urinary stone propulsion device visualizes urinary stones in the upper urinary tract and delivers focused acoustic pulses to reposition the stones to facilitate their passage.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262200 | 2026-07-29 | Sonomotion, Inc. | Stone Clear (BWSC-LP9-02) | |
| DEN230082 | 2024-10-30 | Sonomotion, Inc. | Stone Clear (SC-LP9-01) | — |
Official FDA classification page: QNA
Classification and pathway per current FDA publications. Data from openFDA (CC0).