免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

AdvanCE 胶囊內視鏡遞送設備

K 號：K163495 · 2017-03-10

申請人United States Endoscopy Group, Inc.
決定日期2017-03-10
產品代碼NEZ
諮詢委員會GU
決定相當於

器材摘要

AdvanCE capsule endoscope delivery device is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163495. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AdvanCE capsule endoscope delivery device?

AdvanCE capsule endoscope delivery device is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K163495.

When did AdvanCE capsule endoscope delivery device receive FDA 510(k) clearance?

AdvanCE capsule endoscope delivery device received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163495.

Who is the listed applicant for AdvanCE capsule endoscope delivery device?

The FDA 510(k) record lists United States Endoscopy Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AdvanCE capsule endoscope delivery device?

The FDA product code for AdvanCE capsule endoscope delivery device is NEZ.

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 United States Endoscopy Group, Inc. 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。

K192265gi-4000 電外科電流發生器K200745Lariat, 熱/冷圈K192059生物保護空氣/水及吸引閥K191559AquaShield 系統 CO2, AquaShield 系統 CO2-PENTAX, AquaShield 系統 CO2-FUJIFILMK182909羅思網絡回收器產品線K182258AquaShield 系統 CO2 ; AquaShield 系統 CO2 - PENTAX ; AquaShield 系統 CO2 - Fujifilm

查看所有 10 項裝置 →

相關器械（代碼：NEZ）

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。

K252617MiroCam® 胶囊內視鏡系統Intromedic Co., Ltd.K252480CE交付（DLV）CapsoVision, Inc.K242643CapsoCam Plus (SV-3) 胶囊內視鏡系統CapsoVision, Inc.K240276PillCam™ 天才 SB 系統搭配 PillCam 軟體 v9.7 及 PillCam雲端閱讀軟體Given Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam 小腸顱內鏡系統，配備 NaviCam SB 顱內鏡及 NaviCam 緊繫帶Anx Robotica CorporationK230991PillCam SB 3 胶囊內視鏡系統，PillCam 軟體 9.0EGiven Imaging Ltd. (Medtronic)

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑