FDA 510(k)

HYDROS机器人系统（HY1000）；HYDROS手柄（HH1000）；HYDROS TRUS探头（HU1000）

K号: K260723 · 2026-07-09

决定日期2026-07-09

产品代码PZP

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决定实质等同

器械摘要

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.

常见问题

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.

列明Procept Biorobotics为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253211AQUABEAM 机器人系统 K251082HYDROS机器人系统（HY1000）；HYDROS手柄（HH1000）；HYDROS TRUS探头（HU1000）K241952AQUABEAM 机器人系统（AB2000）K240200HYDROS机器人系统；HYDROS TRUS探头；HYDROS手柄

官方来源

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