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FDA 510(k)

麥格迪恩可伸縮煙霧排氣鉛筆 - 10呎管，麥格迪恩可伸縮煙霧排氣鉛筆 - 15呎管，麥格迪恩可伸縮軟組織解剖鉛筆，麥格迪恩可伸縮軟組織解剖鉛筆

K 號：K200253 · 2020-05-27

申請人Ethicon Endo-Surgery
決定日期2020-05-27
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

Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery. It received FDA 510(k) clearance on 2020-05-27 under 510(k) number K200253. 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 Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector?

Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Ethicon Endo-Surgery. The 510(k) number is K200253.

When did Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector receive FDA 510(k) clearance?

Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector received FDA 510(k) clearance on 2020-05-27, under 510(k) number K200253.

Who is the listed applicant for Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector?

The FDA 510(k) record lists Ethicon Endo-Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector?

The FDA product code for Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector 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

其他以 Ethicon Endo-Surgery 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。

K223760ECHELON LINEAR™ 60mm 切割器 (GLC60)；ECHELON LINEAR™ 80mm 切割器 (GLC80)；ECHELON LINEAR™ 100mm 切割器 (GLC100)；ECHELON LINEAR™ 切割器 60mm 藍色重裝 (GLCR60B)；ECHELON LINEAR™ 切割器 60mm 綠色重裝 (GLCR60G)；ECHELON LINEAR™ 切割器 80mm 藍色重裝 (GLCR80B)；ECHELON LINEAR™ 切割器 80mm 綠色重裝 (GLCR80G)；ECHELON LINEAR™ 切割器 100mm 藍色重裝 (GLCR100B)；ECHELON LINEAR™ 切割器 100mm 綠色重裝 (GLCR100G)

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, LLCK261959Neptune® 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 InstrumentsK261070LigaSure™ RAS 馬里蘭 頰部 血管 黏合器/分離器，納米塗層Covidien, LLCK254185波坦茲·普瑞美Jeisys Medical IncorporatedK262364艾利安恩尼格瑪雷射設備Ellian CorpK253859紅色專業版（Scarlet Pro）VIOL Co., Ltd.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

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