K262200
- 510(k) number
- K262200
- Device name
- Stone Clear (BWSC-LP9-02)
- Applicant
- Sonomotion, Inc. CA · US
- Product code
- QNA — Ultrasonic Urinary Stone Propulsion Device
- Decision date
- 2026-07-29
- Date received
- 2026-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K262200.pdf
Official FDA record: K262200
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.