FDA 510(k)

電漿邊緣切除及氣化電極，電漿邊緣工作元件，電漿邊緣适配器

K 號：K213135 · 2022-03-02

決定日期2022-03-02

產品代碼FAS

諮詢委員會GU

決定相當於

器材摘要

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is the device name listed in this FDA 510(k) record. The listed applicant is Chirurgie Innovation. It received FDA 510(k) clearance on 2022-03-02 under 510(k) number K213135. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is a medical device that received FDA 510(k) clearance on 2022-03-02. The listed applicant is Chirurgie Innovation. The 510(k) number is K213135.

When did Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge receive FDA 510(k) clearance?

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge received FDA 510(k) clearance on 2022-03-02, under 510(k) number K213135.

Who is the listed applicant for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

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

What is the FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge?

The FDA product code for Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge is FAS.

其他以 Chirurgie Innovation 為申請人之記錄

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K163090電漿邊緣系統

相關器械（代碼：FAS）

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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