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FDA 510(k)

多功能操作解剖器（電外科筆）；多功能操作解剖器（一次性電極）

K 號：K260466 · 2026-04-07

申請人Zhejiang shuyou Surgical Instrument Co., Ltd.
決定日期2026-04-07
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

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang shuyou Surgical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K260466. 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 Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Zhejiang shuyou Surgical Instrument Co., Ltd.. The 510(k) number is K260466.

When did Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) receive FDA 510(k) clearance?

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K260466.

Who is the listed applicant for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

The FDA 510(k) record lists Zhejiang shuyou Surgical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

The FDA product code for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable 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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