510(k) K240200

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece by Procept Biorobotics — Product Code PZP

K240200 is an FDA 510(k) premarket notification submitted by Procept Biorobotics for the device "HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece". The FDA issued a decision of Substantially Equivalent on Aug 20, 2024. The device falls under product code PZP (Fluid Jet Removal System), a Class II device regulated under 21 CFR 876.4350. Procept Biorobotics has at least 4 other 510(k) clearances on record.