HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece is an FDA 510(k)-cleared medical device (K240200) manufactured by Procept Biorobotics. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2024. Regulation: 8.