FDA 510(k)

艾露莎可重用中性板

K 號：K222425 · 2022-09-08

決定日期2022-09-08

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 Reusable Neutral Plates is the device name listed in this FDA 510(k) record. The listed applicant is Ellusa, LLC. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K222425. 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 Reusable Neutral Plates?

Ellusa Reusable Neutral Plates is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Ellusa, LLC. The 510(k) number is K222425.

When did Ellusa Reusable Neutral Plates receive FDA 510(k) clearance?

Ellusa Reusable Neutral Plates received FDA 510(k) clearance on 2022-09-08, under 510(k) number K222425.

Who is the listed applicant for Ellusa Reusable Neutral Plates?

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 Reusable Neutral Plates?

The FDA product code for Ellusa Reusable Neutral Plates 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 K202558艾露莎雙極棒 K202562Ellusa 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

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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片，按鈕開關（0703-046-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，按鈕開關，大量非無菌（0703-046-102）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，70mm刀片， rocking 開關（0703-047-100）；Neptune® SafeAir® 10呎煙霧排氣鉛筆，方形包覆，rocking 開關，大量非無菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 馬里蘭頰部血管黏合器/分離器，納米塗層Covidien, LLC K254185波坦茲·普瑞美Jeisys Medical Incorporated K262364艾利安恩尼格瑪雷射設備Ellian Corp K253859紅色專業版（Scarlet Pro）VIOL Co., Ltd.

官方來源

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