FDA 510(k)

HYDROS機器人系統；HYDROS TRUS探針；HYDROS手持式工具

K 號：K240200 · 2024-08-20

決定日期2024-08-20

產品代碼PZP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Procept Biorobotics 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260723HYDROS機器人系統（HY1000）；HYDROS手持式工具（HH1000）；HYDROS TRUS 探頭（HU1000）K253211AQUABEAM Robotic System K251082HYDROS機器人系統（HY1000）；HYDROS手持式工具（HH1000）；HYDROS TRUS 探頭（HU1000）K241952AQUABEAM Robotic System (AB2000)

相關器械（代碼：PZP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260723HYDROS機器人系統（HY1000）；HYDROS手持式工具（HH1000）；HYDROS TRUS 探頭（HU1000）Procept Biorobotics K253211AQUABEAM Robotic SystemProcept Biorobotics K251082HYDROS機器人系統（HY1000）；HYDROS手持式工具（HH1000）；HYDROS TRUS 探頭（HU1000）Procept Biorobotics K241952AQUABEAM Robotic System (AB2000)Procept Biorobotics K231024AquaBeam 閃電系統Procept Biorobotics, Corporation K212835AquaBeam 閃電系統Procept Biorobotics, Corporation

官方來源

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