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)

雙球囊內視鏡 EN-840T，超管 TS-1214C

K 號：K233321 · 2024-06-13

申請人FUJIFILM Healthcare Americas Corporation
決定日期2024-06-13
產品代碼FDA
諮詢委員會GU
決定相當於

器材摘要

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K233321. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K233321.

When did Double Balloon Endoscope EN-840T, Over-tube TS-1214C receive FDA 510(k) clearance?

Double Balloon Endoscope EN-840T, Over-tube TS-1214C received FDA 510(k) clearance on 2024-06-13, under 510(k) number K233321.

Who is the listed applicant for Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C?

The FDA product code for Double Balloon Endoscope EN-840T, Over-tube TS-1214C is FDA.

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 FUJIFILM Healthcare Americas Corporation 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。

K261713Synapse PACS (7.6.0)K251204富士通 stiffening wire device (SW-2000)K243647Synapse PACS (7.5)K233629APERTO Lucent MRI 系統K233687ECHELON 協奏曲 V10.0K233583FCT iSTREAM 開發階段 1

查看所有 13 項裝置 →

相關器械（代碼：FDA）

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。

K260314Ancora-SBAspero Medical, Inc.K251204富士通 stiffening wire device (SW-2000)FUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295內視鏡型號 EN-580T，過管 TS-1314B，氣球 BS-4，管套組 TY-500DFujifilm CorporatonK213195氣球 BS-3Fujifilm CorporationK191330Arc EnterocuffBoddingtons Plastics, Ltd.

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。

↑