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510(k) K251082

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) by Procept Biorobotics — Product Code PZP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 10, 2025
Date Received: April 9, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Fluid Jet Removal System
Device Class: Class II
Regulation Number: 876.4350
Review Panel: GU
Submission Type

The system is used for removal of prostate tissue with a fluid jet.