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FDA 510(k)

無菌單次使用電外科筆，無涂層電極，无菌單次使用電外科筆，不粘電極

K 號：K231405 · 2024-01-18

申請人Jiangsu Rong FU Kang Medical Instruments Co., Ltd.
決定日期2024-01-18
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

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K231405. 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 Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. The 510(k) number is K231405.

When did Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode receive FDA 510(k) clearance?

Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode received FDA 510(k) clearance on 2024-01-18, under 510(k) number K231405.

Who is the listed applicant for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

The FDA 510(k) record lists Jiangsu Rong FU Kang Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode?

The FDA product code for Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode is GEI.

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。

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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。

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官方來源

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