Stone Clear (BWSC-LP9-02)
FDA 510(k) K262200 · Sonomotion, Inc.
510(k) numberK262200
Submission
- Device name
- Stone Clear (BWSC-LP9-02)
- Applicant
- Sonomotion, Inc.
San Mateo, CA, US - Received
- June 29, 2026
- Decision date
- July 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNA – Ultrasonic Urinary Stone Propulsion Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4690
- Specialty
- Gastroenterology, Urology
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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Questions and answers
When was Stone Clear (BWSC-LP9-02) cleared by the FDA?
Stone Clear (BWSC-LP9-02) (K262200) received a 510(k) decision of Substantially Equivalent on July 29, 2026, 30 days after the submission was received.
What is the product code of K262200?
The FDA product code is QNA – Ultrasonic Urinary Stone Propulsion Device, a Class II (moderate risk) device regulated under 21 CFR 876.4690.