Procept Biorobotics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Procept Biorobotics - FDA 510(k) Cleared Devices
Recent clearances: HYDROS Robotic System (HY1000), AQUABEAM Robotic System (AB2000), HYDROS Robotic System
4
Total
4
Cleared
0
Denied
Procept Biorobotics has 4 FDA 510(k) cleared medical devices. Based in San Jose, US.
Latest FDA clearance: Jun 2026. Active since 2024. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Procept Biorobotics Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Procept Biorobotics
4 devices
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