FDA 510(k)

可調向刷式活檢組套

K 號：K191485 · 2019-06-26

決定日期2019-06-26

產品代碼FDX

諮詢委員會GU

決定相當於

器材摘要

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 2019-06-26 under 510(k) number K191485. 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 Deflectable Brush Biopsy Set?

Deflectable Brush Biopsy Set is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Cook Incorporated. The 510(k) number is K191485.

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

Deflectable Brush Biopsy Set received FDA 510(k) clearance on 2019-06-26, under 510(k) number K191485.

Who is the listed applicant for 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 Deflectable Brush Biopsy Set?

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

其他以 Cook Incorporated 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。

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官方來源

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