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FDA 510(k)

AQUABEAM Robotic System (AB2000)

K-Number: K241952 · 2024-09-30

ApplicantProcept Biorobotics
Decision Date2024-09-30
Product CodePZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AQUABEAM Robotic System (AB2000) is a medical device manufactured by Procept Biorobotics. It received FDA 510(k) clearance on 2024-09-30 under approval number K241952. The device is classified under product code PZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUABEAM Robotic System (AB2000)?

AQUABEAM Robotic System (AB2000) is a medical device that received FDA 510(k) clearance on 2024-09-30. It is manufactured by Procept Biorobotics. The 510(k) number is K241952.

When was AQUABEAM Robotic System (AB2000) approved by the FDA?

AQUABEAM Robotic System (AB2000) received FDA 510(k) clearance on 2024-09-30, under approval number K241952.

What company makes AQUABEAM Robotic System (AB2000)?

AQUABEAM Robotic System (AB2000) is manufactured by Procept Biorobotics.

What is the FDA product code for AQUABEAM Robotic System (AB2000)?

The FDA product code for AQUABEAM Robotic System (AB2000) is PZP.

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07566767 Effect of Robotic Gait on Functions in Cerebral Palsy COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Procept Biorobotics

K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Related Devices (Code: PZP)

DEN170024AQUABEAM SystemProcept Biorobotics, Corporation K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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