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FDA 510(k)

切割-抽吸照明煙霧排氣電外科筆

K 號：K170721 · 2017-04-21

申請人Precision Surgical, LLC
決定日期2017-04-21
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

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil is the device name listed in this FDA 510(k) record. The listed applicant is Precision Surgical, LLC. It received FDA 510(k) clearance on 2017-04-21 under 510(k) number K170721. 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 Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil is a medical device that received FDA 510(k) clearance on 2017-04-21. The listed applicant is Precision Surgical, LLC. The 510(k) number is K170721.

When did Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil receive FDA 510(k) clearance?

Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil received FDA 510(k) clearance on 2017-04-21, under 510(k) number K170721.

Who is the listed applicant for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

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

What is the FDA product code for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil?

The FDA product code for Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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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