FDA 510(k)

無刀針 Trocar；有刀針 Trocar；哈遜 Trocar

K 號：K241052 · 2024-10-04

決定日期2024-10-04

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Bladeless Trocar; Bladed Trocar; Hasson Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Advamedix, GmbH. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241052. 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 Bladeless Trocar; Bladed Trocar; Hasson Trocar?

Bladeless Trocar; Bladed Trocar; Hasson Trocar is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Advamedix, GmbH. The 510(k) number is K241052.

When did Bladeless Trocar; Bladed Trocar; Hasson Trocar receive FDA 510(k) clearance?

Bladeless Trocar; Bladed Trocar; Hasson Trocar received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241052.

Who is the listed applicant for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

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

What is the FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar?

The FDA product code for Bladeless Trocar; Bladed Trocar; Hasson Trocar is GCJ.

其他以 Advamedix, GmbH 為申請人之記錄

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K242927吸引灌洗管路組

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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