FDA 510(k)

HYDROS机器人系统；HYDROS TRUS探头；HYDROS手柄

K号: K240200 · 2024-08-20

决定日期2024-08-20

产品代码PZP

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决定实质等同

器械摘要

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Procept Biorobotics. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K240200. 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; HYDROS TRUS Probe; HYDROS Handpiece?

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is Procept Biorobotics. The 510(k) number is K240200.

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

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece received FDA 510(k) clearance on 2024-08-20, under 510(k) number K240200.

Who is the listed applicant for HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece?

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; HYDROS TRUS Probe; HYDROS Handpiece?

The FDA product code for HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece 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。

K260723HYDROS机器人系统（HY1000）；HYDROS手柄（HH1000）；HYDROS TRUS探头（HU1000）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）

官方来源

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