Medical Device Manufacturer · US , San Jose , CA

Procept Biorobotics - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2024

Recent clearances: HYDROS Robotic System (HY1000), AQUABEAM Robotic System (AB2000), HYDROS Robotic System

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Procept Biorobotics Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Jun 23, 2026

AQUABEAM Robotic System

Gastroenterology & Urology · 267d

Cleared Oct 10, 2025

HYDROS Robotic System (HY1000)

Gastroenterology & Urology · 184d

Cleared Sep 30, 2024

AQUABEAM Robotic System (AB2000)

Gastroenterology & Urology · 89d

Cleared Aug 20, 2024

HYDROS Robotic System

Gastroenterology & Urology · 208d