DEN230082
- 510(k) number
- DEN230082
- Device name
- Stone Clear (SC-LP9-01)
- Applicant
- Sonomotion, Inc. CA · US
- Product code
- QNA — Ultrasonic Urinary Stone Propulsion Device
- Decision date
- 2024-10-30
- Date received
- 2023-12-07
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Gastroenterology, Urology
Official FDA record: DEN230082
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.