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FDA 510(k)

CoralView® 一次性使用數位柔軟輸尿管鏡 (U10)；CoralView® 一次性使用數位柔軟輸尿管鏡 (U10-B)；CoralView® 一次性使用數位柔軟輸尿管鏡 (U10-BR)；CoralView® 一次性使用數位柔軟輸尿管鏡 (U20)；CoralView® 一次性使用數位柔軟輸尿管鏡 (U20-B)；CoralView® 一次性使用數位柔軟輸尿管鏡 (U20-BR)

K 號：K231774 · 2024-01-11

申請人MacroLux Medical Technology Co., Ltd.
決定日期2024-01-11
產品代碼FGB
諮詢委員會GU
決定相當於

器材摘要

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) is the device name listed in this FDA 510(k) record. The listed applicant is MacroLux Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K231774. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)?

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is MacroLux Medical Technology Co., Ltd.. The 510(k) number is K231774.

When did CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) receive FDA 510(k) clearance?

CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K231774.

Who is the listed applicant for CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)?

FDA 510(k) 記錄將宏麗克斯醫療技術有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)?

The FDA product code for CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) is FGB.

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。

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其他以 MacroLux Medical Technology Co., 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。

K260516泡泡視單次使用數位柔軟膀胱鏡（C38-CS、C38-CRS、C50-C、C50-CR、C50-CB、C50-CBR）K260420LoopView®單次使用數位柔軟式氣管內鏡（B27-C，B27-CG）K250452CoralWell™ 單次使用輸尿管進入鞘 (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)K240978SeleneView®單次使用數位宮頸鏡（HC29、HC29-G、HC35、HC35-G、HO35、HO35-G、HO42、HO42-G）K240283BubbleView™單次使用數位柔軟膀胱鏡（C50-C、C50-CR、C50-CB、C50-CBR）；ViewHub®視頻處理器（S13、S13-T、S13-N、S13-S）K233779LoopView®單次使用數位柔軟式氣管內視鏡（B38、B38-C、B50、B50-C、B58、B58-C），ViewHub®視頻處理器（S13）

查看所有 7 項裝置 →

相關器械（代碼：FGB）

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。

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官方來源

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