Stone Clear (BWSC-LP9-02)— 510(k) K262200
Substantially EquivalentSonomotion, Inc.
FDA 510(k) clearance K262200 for Stone Clear (BWSC-LP9-02), Substantially Equivalent on 2026-07-29. Applicant: Sonomotion, Inc.. Device class: 2.
Summary
Sonomotion's Stone Clear (BWSC-LP9-02) is filed under QNA, ultrasonic urinary stone propulsion devices. The record gives the model as BWSC-LP9-02 but no specs.
Class II, 21 CFR 876.4690. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Special 510(k).
Sonomotion filed from San Mateo, California. The decision came 30 calendar days after receipt (June 29 to July 29, 2026).
Clearance details
- Applicant
- Sonomotion, Inc.
- Product code
- Product code QNA
- Device class
- Class 2
- Regulation
- 21 CFR 876.4690
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Mateo, CA, US
Recent devices under product code QNA
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