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FDA 510(k)

NaviCam 胶囊內視鏡系統，搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線，NaviCam Xpress 胃膽胶囊內視鏡系統（NaviCam Xpress 胃膽系統），搭配 NaviCam 胃膽胶囊及 NaviCam 緊縮線

K 號：K221608 · 2022-11-22

申請人Anx Robotica Corp
決定日期2022-11-22
產品代碼QKZ
諮詢委員會GU
決定相當於

器材摘要

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corp. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K221608. The device is classified under product code QKZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether?

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Anx Robotica Corp. The 510(k) number is K221608.

When did NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether receive FDA 510(k) clearance?

NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether received FDA 510(k) clearance on 2022-11-22, under 510(k) number K221608.

Who is the listed applicant for NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether?

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

What is the FDA product code for NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether?

The FDA product code for NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether is QKZ.

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 Anx Robotica Corp 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。

K241934NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 胃囊/繩索（NaviCam Xpress 胃系統搭配 NaviCam 標籤/繩索）K230694NaviCam Xpress 胃系統，NaviCam Xpress 系統K203192NaviCam Xpress 胃部系統K201106IntraMarX 3D 放射性不透明標記K191087內馬克X 放射性顯影標記

相關器械（代碼：QKZ）

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。

K241934NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 胃囊/繩索（NaviCam Xpress 胃系統搭配 NaviCam 標籤/繩索）Anx Robotica CorpK231960NaviCam Xpress 胃囊內視鏡系統（NaviCam Xpress 胃系統）搭配 NaviCam 擋桿及 NaviCam 緊繫器Anx Robotica CorporationK230694NaviCam Xpress 胃系統，NaviCam Xpress 系統Anx Robotica CorpK203192NaviCam Xpress 胃部系統Anx Robotica Corp

官方來源

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