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FDA 510(k)

一次性腹部套管針(刀片式套管針、無刀片式套管針、光學套管針)

K 號:K232866 · 2023-11-07

決定日期2023-11-07
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Channel Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K232866. 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 Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)?

Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Jiangsu Channel Medical Device Co., Ltd.. The 510(k) number is K232866.

When did Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) receive FDA 510(k) clearance?

Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) received FDA 510(k) clearance on 2023-11-07, under 510(k) number K232866.

Who is the listed applicant for Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)?

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

What is the FDA product code for Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars)?

The FDA product code for Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) is GCJ.

相關臨床試驗

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。

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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