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FDA 510(k)

M 精準切片 /SureCore 一次性自動切片針，M 精準切片 /SureCore 半自動一次性切片針，M 精準切片 /SureAim 同軸切片針

K 號：K222865 · 2023-04-03

申請人Canyon Medical, Inc.
決定日期2023-04-03
產品代碼KNW
諮詢委員會GU
決定相當於

器材摘要

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Medical, Inc.. It received FDA 510(k) clearance on 2023-04-03 under 510(k) number K222865. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle?

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2023-04-03. The listed applicant is Canyon Medical, Inc.. The 510(k) number is K222865.

When did M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle receive FDA 510(k) clearance?

M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle received FDA 510(k) clearance on 2023-04-03, under 510(k) number K222865.

Who is the listed applicant for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle?

FDA 510(k) 記錄將 Canyon Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle?

The FDA product code for M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle is KNW.

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 Canyon Medical, 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。

K254179引流針管K250209聚乙烯醇栓塞微球K241827微波消融發生器（KY-2000A、KY-2100A）K241825微波消融天線K233031M·組織切片 /SureCore 自动一次性組織切片針，M·組織切片 /SureCore 半自動一次性組織切片針，M·組織切片 /SureAim 同軸組織切片針

相關器械（代碼：KNW）

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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