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FDA 510(k)

綠色或再處理Aquamantys雙極封合器

K 號:K211203 · 2022-04-07

申請人Green Or, LLC
決定日期2022-04-07
產品代碼NUJ
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

Green OR Reprocessed Aquamantys Bipolar Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Green Or, LLC. It received FDA 510(k) clearance on 2022-04-07 under 510(k) number K211203. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Green OR Reprocessed Aquamantys Bipolar Sealer?

Green OR Reprocessed Aquamantys Bipolar Sealer is a medical device that received FDA 510(k) clearance on 2022-04-07. The listed applicant is Green Or, LLC. The 510(k) number is K211203.

When did Green OR Reprocessed Aquamantys Bipolar Sealer receive FDA 510(k) clearance?

Green OR Reprocessed Aquamantys Bipolar Sealer received FDA 510(k) clearance on 2022-04-07, under 510(k) number K211203.

Who is the listed applicant for Green OR Reprocessed Aquamantys Bipolar Sealer?

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

What is the FDA product code for Green OR Reprocessed Aquamantys Bipolar Sealer?

The FDA product code for Green OR Reprocessed Aquamantys Bipolar Sealer is NUJ.

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:NUJ)

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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