FDA 510(k)

ClearTip FNA及FNB型別

K 號：K250994 · 2025-08-21

決定日期2025-08-21

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

ClearTip FNA and FNB Types 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 2025-08-21 under 510(k) number K250994. 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 ClearTip FNA and FNB Types?

ClearTip FNA and FNB Types is a medical device that received FDA 510(k) clearance on 2025-08-21. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K250994.

When did ClearTip FNA and FNB Types receive FDA 510(k) clearance?

ClearTip FNA and FNB Types received FDA 510(k) clearance on 2025-08-21, under 510(k) number K250994.

Who is the listed applicant for ClearTip FNA and FNB Types?

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 ClearTip FNA and FNB Types?

The FDA product code for ClearTip FNA and FNB Types 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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