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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 the device name listed in this FDA 510(k) record. The listed applicant is Procept Biorobotics. It received FDA 510(k) clearance on 2025-10-10 under 510(k) 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. The listed applicant is Procept Biorobotics. The 510(k) number is K251082.

When did HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) receive FDA 510(k) clearance?

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

Who is the listed applicant for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)?

The FDA 510(k) record lists Procept Biorobotics as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07650448WATER IV PCa (AS Sub-study)NOT_YET_RECRUITING

Other records listing Procept Biorobotics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)K253211AQUABEAM Robotic SystemK241952AQUABEAM Robotic System (AB2000)K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceK231024AquaBeam Robotic SystemK212835AquaBeam Robotic System

View all 8 devices →

Related Devices (Code: PZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260723HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)Procept BioroboticsK253211AQUABEAM Robotic SystemProcept BioroboticsK241952AQUABEAM Robotic System (AB2000)Procept BioroboticsK240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept BioroboticsK231024AquaBeam Robotic SystemProcept Biorobotics, CorporationK212835AquaBeam Robotic SystemProcept Biorobotics, Corporation

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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