510(k) K262200
K262200 is an FDA 510(k) premarket notification submitted by Sonomotion, Inc. for the device "Stone Clear (BWSC-LP9-02)". The FDA issued a decision of Substantially Equivalent on July 29, 2026. 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
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2026
- Date Received
- June 29, 2026
- Clearance Type
- Special
- 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.