FDA 510(k)

清晰針EUS-FNA

K 號：K180363 · 2018-11-01

決定日期2018-11-01

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

Clear-Tip EUS-FNA is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2018-11-01 under 510(k) number K180363. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Clear-Tip EUS-FNA?

Clear-Tip EUS-FNA is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K180363.

When did Clear-Tip EUS-FNA receive FDA 510(k) clearance?

Clear-Tip EUS-FNA received FDA 510(k) clearance on 2018-11-01, under 510(k) number K180363.

Who is the listed applicant for Clear-Tip EUS-FNA?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear-Tip EUS-FNA?

The FDA product code for Clear-Tip EUS-FNA is FCG.

其他以 Finemedix Co., Ltd. 為申請人之記錄

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相關器械（代碼：FCG）

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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