General_plastic_surgery

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Procept Biorobotics

FDA-cleared AI medical device

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

FDA Submission Metadata

Submission number
K251082
Decision date
October 2025
FDA panel
General and Plastic Surgery
Product code
PZP

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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