FDA 510(k)

刷式切片組；可偏轉刷式切片組

K 號：K182231 · 2019-05-01

決定日期2019-05-01

產品代碼FDX

諮詢委員會GU

決定相當於

器材摘要

Brush Biopsy Set ; Deflectable Brush Biopsy Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K182231. 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 Brush Biopsy Set ; Deflectable Brush Biopsy Set?

Brush Biopsy Set ; Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Cook Incorporated. The 510(k) number is K182231.

When did Brush Biopsy Set ; Deflectable Brush Biopsy Set receive FDA 510(k) clearance?

Brush Biopsy Set ; Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-05-01, under 510(k) number K182231.

Who is the listed applicant for Brush Biopsy Set ; Deflectable Brush Biopsy Set?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set?

The FDA product code for Brush Biopsy Set ; Deflectable Brush Biopsy Set is FDX.

其他以 Cook Incorporated 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。

K233177Nest VT 液化設備 K222254蓮花Vena Cava Filter 取出組 K223098巴克里基本產後氣球 K210734內血管擴張器及套件 K203670超大檢查通導管 K191498庫克-科普迴路腎盂造口套件，超膠劑腎盂造口套件配麥洛克，超膠劑會陰造口套件配麥洛克

查看所有 146 項裝置 →

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 K181317融合細胞學刷，CytoMax II雙腔細胞學刷Wilson-Cook Medical, Inc.K172663細胞刷Micro-Tech (Nanjing) Co., 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。