FDA 510(k)

Voyant® 電外科電流發生器 (EA030/電外科電流發生器)

K 號：K252412 · 2025-10-31

申請人Applied Medical Resources Corporation

決定日期2025-10-31

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

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2025-10-31 under 510(k) number K252412. 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 Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is a medical device that received FDA 510(k) clearance on 2025-10-31. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K252412.

When did Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) receive FDA 510(k) clearance?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) received FDA 510(k) clearance on 2025-10-31, under 510(k) number K252412.

Who is the listed applicant for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

The FDA 510(k) record lists Applied Medical Resources Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

The FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is GEI.

其他以 Applied Medical Resources Corporation 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。

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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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