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FDA 510(k)

Anovo外科系統（型號6Ne）

K 號：K242157 · 2024-10-21

申請人Momentis Surgical , Ltd.
決定日期2024-10-21
產品代碼QNM
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

Anovo Surgical System (Model 6Ne) is the device name listed in this FDA 510(k) record. The listed applicant is Momentis Surgical , Ltd.. It received FDA 510(k) clearance on 2024-10-21 under 510(k) number K242157. The device is classified under product code QNM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Anovo Surgical System (Model 6Ne)?

Anovo Surgical System (Model 6Ne) is a medical device that received FDA 510(k) clearance on 2024-10-21. The listed applicant is Momentis Surgical , Ltd.. The 510(k) number is K242157.

When did Anovo Surgical System (Model 6Ne) receive FDA 510(k) clearance?

Anovo Surgical System (Model 6Ne) received FDA 510(k) clearance on 2024-10-21, under 510(k) number K242157.

Who is the listed applicant for Anovo Surgical System (Model 6Ne)?

FDA 510(k) 記錄將 Momentis Surgical, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Anovo Surgical System (Model 6Ne)?

The FDA product code for Anovo Surgical System (Model 6Ne) is QNM.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Momentis Surgical , Ltd. 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。

K260804Anovo外科系統（6Ne）K251761Anovo外科系統（型號6Ne）；Anovo儀器ARM曲型剪；Anovo儀器ARM勾電極K250591Anovo Surgical System (6Ne)K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeK243182Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeK241907Anovo Surgical System (model 6N)

查看所有 8 項裝置 →

相關器械（代碼：QNM）

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。

K251761Anovo外科系統（型號6Ne）；Anovo儀器ARM曲型剪；Anovo儀器ARM勾電極Momentis Surgical , Ltd.K250591Anovo Surgical System (6Ne)Momentis Surgical , Ltd.K251056Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd.K243182Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook ElectrodeMomentis Surgical , Ltd.K241907Anovo Surgical System (model 6N)Momentis Surgical , Ltd.K232146Anovo PedestalMomentis Surgical , Ltd.

官方來源

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