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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 K251082
Device Name HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Applicant
Procept Biorobotics
150 Baytech Dr.
San Jose,  CA  95134
Applicant Contact Bijesh Chandran
Correspondent
Procept Biorobotics
150 Baytech Dr.
San Jose,  CA  95134
Correspondent Contact Bijesh Chandran
Regulation Number876.4350
Classification Product Code
PZP  
Subsequent Product Code
ITX  
Date Received04/09/2025
Decision Date 10/10/2025
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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