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FDA 510(k)

VersaOne 刃片式套管針 5mm

K 號:K152149 · 2016-01-22

申請人Covidien
決定日期2016-01-22
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

VersaOne Bladed Trocar 5mm is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152149. 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 VersaOne Bladed Trocar 5mm?

VersaOne Bladed Trocar 5mm is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Covidien. The 510(k) number is K152149.

When did VersaOne Bladed Trocar 5mm receive FDA 510(k) clearance?

VersaOne Bladed Trocar 5mm received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152149.

Who is the listed applicant for VersaOne Bladed Trocar 5mm?

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

What is the FDA product code for VersaOne Bladed Trocar 5mm?

The FDA product code for VersaOne Bladed Trocar 5mm is GCJ.

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其他以 Covidien 為申請人之記錄

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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。

官方來源

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