Procept Biorobotics

FDA Regulatory Profile

Procept Biorobotics appears in FDA public data with 0 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 9, 2026.

Summary

Total Recalls
0
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Jul 9, 2026
K253211AQUABEAM Robotic SystemJun 23, 2026
K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Oct 10, 2025
K241952AQUABEAM Robotic System (AB2000)Sep 30, 2024
K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceAug 20, 2024