FDA 510(k)

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

Número K: K260723 · 2026-07-09

Data da decisão2026-07-09

Código do produtoPZP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2026-07-09 under 510(k) number K260723. The device is classified under product code PZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2026-07-09. The listed applicant is Procept Biorobotics. The 510(k) number is K260723.

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 2026-07-09, under 510(k) number K260723.

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.

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Outros registros que listam Procept Biorobotics como candidato(a)

K253211Sistema Robótico AQUABEAM K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)K241952Sistema Robótico AQUABEAM (AB2000)K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

Dispositivos Relacionados (Código: PZP)

K253211Sistema Robótico AQUABEAMProcept Biorobotics K251082HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)Procept Biorobotics K241952Sistema Robótico AQUABEAM (AB2000)Procept Biorobotics K240200HYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceProcept Biorobotics K231024Sistema Robótico AquaBeamProcept Biorobotics, Corporation K212835Sistema Robótico AquaBeamProcept Biorobotics, Corporation

Fonte oficial

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