FDA 510(k)

一次性單極內視鏡針尖及可重複使用把手

K 號：K211019 · 2021-10-28

決定日期2021-10-28

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Disposable Monopolar Laparoscopic Tips and Reusable Handles is the device name listed in this FDA 510(k) record. The listed applicant is Dannik, LLC. It received FDA 510(k) clearance on 2021-10-28 under 510(k) number K211019. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Monopolar Laparoscopic Tips and Reusable Handles?

Disposable Monopolar Laparoscopic Tips and Reusable Handles is a medical device that received FDA 510(k) clearance on 2021-10-28. The listed applicant is Dannik, LLC. The 510(k) number is K211019.

When did Disposable Monopolar Laparoscopic Tips and Reusable Handles receive FDA 510(k) clearance?

Disposable Monopolar Laparoscopic Tips and Reusable Handles received FDA 510(k) clearance on 2021-10-28, under 510(k) number K211019.

Who is the listed applicant for Disposable Monopolar Laparoscopic Tips and Reusable Handles?

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

What is the FDA product code for Disposable Monopolar Laparoscopic Tips and Reusable Handles?

The FDA product code for Disposable Monopolar Laparoscopic Tips and Reusable Handles is GEI.

其他以 Dannik, LLC 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。

K250411DANNIK® 開放式單次使用多樣本回收系統 K210569一次性單極腹腔鏡軸桿及可重複使用手柄

相關器械（代碼：GEI）

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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