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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Urinary Stone Propulsion Device
510(k) Number K262200
Device Name Stone Clear (BWSC-LP9-02)
Applicant
Sonomotion, Inc.
1600 W. Hillsdale Blvd., Suite 105
San Mateo,  CA  94402
Applicant Contact Emily Hergenreter
Correspondent
Sonomotion, Inc.
1600 W. Hillsdale Blvd., Suite 105
San Mateo,  CA  94402
Correspondent Contact Emily Hergenreter
Classification Product Code
QNA  
Date Received06/29/2026
Decision Date 07/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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