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Procept Biorobotics
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K251082
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
October 10, 2025
K241952
AQUABEAM Robotic System (AB2000)
September 30, 2024
K240200
HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
August 20, 2024