FDA 510(k)

麥斯特系統（REF100）

K 號：K242323 · 2025-03-14

決定日期2025-03-14

產品代碼QZB

諮詢委員會GU

決定相當於

器材摘要

Maestro System (REF100) is the device name listed in this FDA 510(k) record. The listed applicant is Moon Surgical. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K242323. The device is classified under product code QZB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Maestro System (REF100)?

Maestro System (REF100) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Moon Surgical. The 510(k) number is K242323.

When did Maestro System (REF100) receive FDA 510(k) clearance?

Maestro System (REF100) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K242323.

Who is the listed applicant for Maestro System (REF100)?

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

What is the FDA product code for Maestro System (REF100)?

The FDA product code for Maestro System (REF100) is QZB.

其他以 Moon Surgical 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。

K250984麥斯特系統（REF100）K240598麥斯特系統（REF100）K221410麥斯特羅平台

相關器械（代碼：QZB）

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。

K261573內鏡固定器（182214）Aktormed GmbH K250984麥斯特系統（REF100）Moon Surgical K233312SOLOASSIST IID / DEXTER內視鏡臂（212499）；ARTip單一（202426）+ ARTip單一語音（202445）；SOLOASSIST II（141364）+ 語音控制（171894）Aktormed GmbH

官方來源

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