FDA 510(k)

Inno-Port 一次性無刀片套管，Inno-Port 一次性光學套管

K 號：K223593 · 2023-03-22

決定日期2023-03-22

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Surgical Corporation. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K223593. 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 Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Taiwan Surgical Corporation. The 510(k) number is K223593.

When did Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar receive FDA 510(k) clearance?

Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar received FDA 510(k) clearance on 2023-03-22, under 510(k) number K223593.

Who is the listed applicant for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

FDA 510(k) 記錄中將台灣外科股份有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar?

The FDA product code for Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar is GCJ.

其他以 Taiwan Surgical Corporation 為申請人之記錄

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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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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