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FDA 510(k)

Veloxion控制器套件、Veloxion流體控制組、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢棄物管理管路、組織捕集器、廢棄物管理袋

K 號：K191341 · 2019-06-13

申請人Corinth Medtech, Inc.
決定日期2019-06-13
產品代碼FJL
諮詢委員會GU
決定相當於

器材摘要

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags is the device name listed in this FDA 510(k) record. The listed applicant is Corinth Medtech, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K191341. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags?

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Corinth Medtech, Inc.. The 510(k) number is K191341.

When did Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags receive FDA 510(k) clearance?

Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags received FDA 510(k) clearance on 2019-06-13, under 510(k) number K191341.

Who is the listed applicant for Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags?

The FDA 510(k) record lists Corinth Medtech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags?

The FDA product code for Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags is FJL.

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 Corinth Medtech, 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。

K230205維洛西昂系統K191335Veloxion控制器套件、Veloxion流體控制組、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢棄物管理管路、組織捕集器、廢棄物管理袋K190113Veloxion控制器套件、Veloxion流體控制組、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢棄物管理管路、組織捕集器、廢棄物管理袋K190099Veloxion控制器套件、Veloxion流體控制套件、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢物管理管路、組織捕集器K180752Veloxion系統、Veloxion控制器套件、Veloxion切除設備套件、Veloxion流體控制組、Veloxion鹽水桿K162979維洛西昂系統

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相關器械（代碼：FJL）

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。

K232486KARL STORZ 高頻電切鏡，配備高頻電纜Karl Storz SE & CO. KGK221893KARL STORZ 兩極切除鏡，配備高頻電纜Karl Storz Endoscopy America, Inc.K230205維洛西昂系統Corinth Medtech, Inc.K190099Veloxion控制器套件、Veloxion流體控制套件、Veloxion切除鏡、Veloxion視頻控制單元、Veloxion輪轉架、廢物管理管路、組織捕集器Corinth Medtech, Inc.K162979維洛西昂系統Corinth Medtech, Inc.

官方來源

在 FDA 資料庫中查看 →

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