510(k) DEN230082
DEN230082 is an FDA 510(k) premarket notification submitted by Sonomotion, Inc. for the device "Stone Clear (SC-LP9-01)". The FDA issued a decision of De Novo Granted on October 30, 2024. The device falls under product code QNA (Ultrasonic Urinary Stone Propulsion Device), a Class II device regulated under 21 CFR 876.4690. Sonomotion, Inc. has at least 3 other 510(k) clearances on record.
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.