QNA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrasonic Urinary Stone Propulsion Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4690
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Stone Clear (BWSC-LP9-02) (K262200) | Sonomotion, Inc. | 2026-07-29 |
| Stone Clear (SC-LP9-01) (DEN230082) | Sonomotion, Inc. | 2024-10-30 |
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