FDA 510(k)

U-IGNITE 電動無刀片套管

K 號：K162387 · 2017-01-11

申請人Tianjin Uwell Medical Device Manufacturing Co., Ltd.

決定日期2017-01-11

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

U-IGNITE Bladeless Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162387. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the U-IGNITE Bladeless Trocar?

U-IGNITE Bladeless Trocar is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Tianjin Uwell Medical Device Manufacturing Co., Ltd.. The 510(k) number is K162387.

When did U-IGNITE Bladeless Trocar receive FDA 510(k) clearance?

U-IGNITE Bladeless Trocar received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162387.

Who is the listed applicant for U-IGNITE Bladeless Trocar?

The FDA 510(k) record lists Tianjin Uwell Medical Device Manufacturing Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-IGNITE Bladeless Trocar?

The FDA product code for U-IGNITE Bladeless Trocar is GCJ.

其他以 Tianjin Uwell Medical Device Manufacturing Co., Ltd. 為申請人之記錄

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K162648U-Blade 腹腔針

相關器械（代碼：GCJ）

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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