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FDA 510(k)

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

K-Number: K251082 · 2025-10-10

ApplicantProcept Biorobotics
Decision Date2025-10-10
Product CodePZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) is a medical device manufactured by Procept Biorobotics. It received FDA 510(k) clearance on 2025-10-10 under approval number K251082. 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 HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)?

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Procept Biorobotics. The 510(k) number is K251082.

When was HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) approved by the FDA?

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) received FDA 510(k) clearance on 2025-10-10, under approval number K251082.

What company makes HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)?

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) is manufactured by Procept Biorobotics.

What is the FDA product code for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)?

The FDA product code for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) 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 NCT06112418 A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events 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

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

K241952AQUABEAM Robotic System (AB2000) K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

Related Devices (Code: PZP)

DEN170024AQUABEAM SystemProcept Biorobotics, Corporation K212835AquaBeam Robotic SystemProcept Biorobotics, Corporation K202961AquaBeam Robotic SystemProcept Biorobotics, Corporation K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept 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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