# Procept Biorobotics

- Location (FDA's records): San Jose, CA
- FDA decisions: 9 (2017–2026): 8 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Procept Biorobotics (5); Procept Biorobotics, Corporation (4)
- Product codes: PZP (9)
- Predicates its devices cite: 9 (9 its own); citations of its devices by later devices: 9 (9 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (2024), cited by 2
- DEN170024: AQUABEAM System (2017), cited by 2
- K231024: AquaBeam Robotic System (2023), cited by 2
- K212835: AquaBeam Robotic System (2021), cited by 1
- K241952: AQUABEAM Robotic System (AB2000) (2024), cited by 1
- K202961: AquaBeam Robotic System (2021), cited by 1

## Recent decisions
- K260723: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (Jul 9, 2026)
- K253211: AQUABEAM Robotic System (Jun 23, 2026)
- K251082: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (Oct 10, 2025)
- K241952: AQUABEAM Robotic System (AB2000) (Sep 30, 2024)
- K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (Aug 20, 2024)
- K231024: AquaBeam Robotic System (Aug 30, 2023)
- K212835: AquaBeam Robotic System (Oct 6, 2021)
- K202961: AquaBeam Robotic System (Mar 11, 2021)

Source page: https://510kreport.com/company/procept-biorobotics