FDA 510(k)

Ellusa 產品系列，包括 Ellusa 集成器、Ellusa 鋒嘴、Ellusa RF-Cobb 鋒嘴、Ellusa SP-Pack 及尖嘴組合、Ellusa 尖嘴組

K 號：K202562 · 2020-11-02

決定日期2020-11-02

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

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is the device name listed in this FDA 510(k) record. The listed applicant is Ellusa, LLC. It received FDA 510(k) clearance on 2020-11-02 under 510(k) number K202562. 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 Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is a medical device that received FDA 510(k) clearance on 2020-11-02. The listed applicant is Ellusa, LLC. The 510(k) number is K202562.

When did Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set receive FDA 510(k) clearance?

Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set received FDA 510(k) clearance on 2020-11-02, under 510(k) number K202562.

Who is the listed applicant for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

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

What is the FDA product code for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set?

The FDA product code for Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set is GEI.

其他以 Ellusa, 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。

K222429艾露莎可重用雙極電纜 K222425艾露莎可重用中性板 K202558艾露莎雙極棒

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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