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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluid Jet Removal System
510(k) Number K253211
Device Name AQUABEAM Robotic System
Applicant
Procept Biorobotics
150 Baytech Dr.
San Jose,  CA  95134
Applicant Contact Ankur Kaushal
Correspondent
Procept Biorobotics
150 Baytech Dr.
San Jose,  CA  95134
Correspondent Contact Ankur Kaushal
Regulation Number876.4350
Classification Product Code
PZP  
Date Received09/29/2025
Decision Date 06/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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