FDA 510(k)

融合細胞學刷，CytoMax II雙腔細胞學刷

K 號：K181317 · 2019-02-08

決定日期2019-02-08

產品代碼FDX

諮詢委員會GU

決定相當於

器材摘要

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181317. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K181317.

When did Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush receive FDA 510(k) clearance?

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181317.

Who is the listed applicant for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush?

The FDA product code for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush is FDX.

其他以 Wilson-Cook Medical, Inc. 為申請人之記錄

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相關器械（代碼：FDX）

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。

K250993單次使用細胞學刷V型（BC-V600P-3010）Olympus Medical Systems Corporation K220063單次使用細胞學刷Zhejiang Chuangxiang Medical Technology Co., Ltd.K192908融合細胞學刷，CytoMax II雙腔細胞學刷Wilson-Cook Medical, Inc.K191485可調向刷式活檢組套Cook Incorporated K182231刷式切片組；可偏轉刷式切片組Cook Incorporated K172663細胞刷Micro-Tech (Nanjing) Co., Ltd.

官方來源

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