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FDA 510(k)

VersaOne光學套管 15mm，VersaOne無刀套管 15mm

K 號：K160230 · 2016-03-01

申請人Covidien
決定日期2016-03-01
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K160230. 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 Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Covidien. The 510(k) number is K160230.

When did VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm receive FDA 510(k) clearance?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm received FDA 510(k) clearance on 2016-03-01, under 510(k) number K160230.

Who is the listed applicant for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

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 Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

The FDA product code for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm 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。

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官方來源

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