510(k) DEN230082
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 30, 2024
- Date Received
- December 7, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Urinary Stone Propulsion Device
- Device Class
- Class II
- Regulation Number
- 876.4690
- Review Panel
- GU
- Submission Type
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.