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FDA 510(k)

Echelon Contour Curved Cutter 藍色重裝刀片，Echelon Contour Curved Cutter 綠色重裝刀片，Echelon Contour Curved Cutter 重裝刀片，藍色，Echelon Contour Curved Cutter 重裝刀片，綠色

K 號：K200420 · 2020-06-29

申請人Ethicon Endo-Surgery, LLC
決定日期2020-06-29
產品代碼GDW
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

Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K200420. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green?

Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K200420.

When did Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green receive FDA 510(k) clearance?

Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green received FDA 510(k) clearance on 2020-06-29, under 510(k) number K200420.

Who is the listed applicant for Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green?

FDA 510(k) 記錄中將 Ethicon Endo-Surgery, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green?

The FDA product code for Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green is GDW.

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, LLC 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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）K260196ETHICON™ 圆形釘釘器 (CDH21mm)；ETHICON™ 圓形釘釘器 (CDH25mm)；ETHICON™ 圓形釘釘器 (CDH29mm)；ETHICON™ 圓形釘釘器 (CDH33mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS21mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS25mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS29mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS33mm)K252906ECHELON ENDOPATH 鍵線強化器 (ECH60R)K252739ETHICON™ 4000 45mm 縮小式釘合器 (EC3DT45C)；ETHICON™ 4000 45mm 标準釘合器 (EC3DT45S)；ETHICON™ 4000 45mm 長釘合器 (EC3DT45L)；ETHICON™ 3D 45mm 白色重裝 (ER45W)；ETHICON™ 3D 45mm 藍色重裝 (ER45B)；ETHICON™ 3D 45mm 綠色重裝 (ER45G)；ETHICON™ 3D 45mm 黑色重裝 (ER45T)K250835ETHICON 4000 60mm 細型釘合器 (EC3D60C)；ETHICON 4000 60mm 标準釘合器 (EC3D60S)；ETHICON 4000 60mm 長型釘合器 (EC3D60L)；ETHICON 3D 60mm 白色重裝 (ER60W)；ETHICON 3D 60mm 藍色重裝 (ER60B)；ETHICON 3D 60mm 綠色重裝 (ER60G)；ETHICON 3D 60mm 黑色重裝 (ER60T)K243276ECHELON LINEAR™ 鋳釘器 30mm 鋳釘器（GTX30）；ECHELON LINEAR™ 鋳釘器 60mm 鋳釘器（GTX60）；ECHELON LINEAR™ 鋳釘器 90mm 鋳釘器（GTX90）；ECHELON LINEAR™ 鋳釘器 3D 30mm 藍色重裝（GTXR30B）；ECHELON LINEAR™ 鋳釘器 3D 30mm 綠色重裝（GTXR30G）；ECHELON LINEAR™ 鋳釘器 3D 60mm 藍色重裝（GTXR60B）；ECHELON LINEAR™ 鋳釘器 3D 60mm 綠色重裝（GTXR60G）；ECHELON LINEAR™ 鋳釘器 3D 90mm 藍色重裝（GTXR90B）；ECHELON LINEAR™ 鋳釘器 3D 90mm 綠色重裝（GTXR90G）

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相關器械（代碼：GDW）

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。

K254291easyEndo™ E-Lite 單次使用電動內視鏡釘合器；easyEndo™ E-Lite 單次使用電動內視鏡釘合器（曲釘）；easyEndo™ E-Lite 單次使用釘合器彈匣Ezisurg Medical Co., Ltd.K260196ETHICON™ 圆形釘釘器 (CDH21mm)；ETHICON™ 圓形釘釘器 (CDH25mm)；ETHICON™ 圓形釘釘器 (CDH29mm)；ETHICON™ 圓形釘釘器 (CDH33mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS21mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS25mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS29mm)；ETHICON™ 圆形釘釘器 - XL 密封 (ECS33mm)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ 重裝；Endo GIA™ 重裝搭配 Tri-Staple™ 技術；Endo GIA™ 灰色可動重裝；Signia™ 小直徑重裝Covidien (Part of Medtronic)K252739ETHICON™ 4000 45mm 縮小式釘合器 (EC3DT45C)；ETHICON™ 4000 45mm 标準釘合器 (EC3DT45S)；ETHICON™ 4000 45mm 長釘合器 (EC3DT45L)；ETHICON™ 3D 45mm 白色重裝 (ER45W)；ETHICON™ 3D 45mm 藍色重裝 (ER45B)；ETHICON™ 3D 45mm 綠色重裝 (ER45G)；ETHICON™ 3D 45mm 黑色重裝 (ER45T)Ethicon Endo-Surgery, LLCK250835ETHICON 4000 60mm 細型釘合器 (EC3D60C)；ETHICON 4000 60mm 标準釘合器 (EC3D60S)；ETHICON 4000 60mm 長型釘合器 (EC3D60L)；ETHICON 3D 60mm 白色重裝 (ER60W)；ETHICON 3D 60mm 藍色重裝 (ER60B)；ETHICON 3D 60mm 綠色重裝 (ER60G)；ETHICON 3D 60mm 黑色重裝 (ER60T)Ethicon Endo-Surgery, LLCK243276ECHELON LINEAR™ 鋳釘器 30mm 鋳釘器（GTX30）；ECHELON LINEAR™ 鋳釘器 60mm 鋳釘器（GTX60）；ECHELON LINEAR™ 鋳釘器 90mm 鋳釘器（GTX90）；ECHELON LINEAR™ 鋳釘器 3D 30mm 藍色重裝（GTXR30B）；ECHELON LINEAR™ 鋳釘器 3D 30mm 綠色重裝（GTXR30G）；ECHELON LINEAR™ 鋳釘器 3D 60mm 藍色重裝（GTXR60B）；ECHELON LINEAR™ 鋳釘器 3D 60mm 綠色重裝（GTXR60G）；ECHELON LINEAR™ 鋳釘器 3D 90mm 藍色重裝（GTXR90B）；ECHELON LINEAR™ 鋳釘器 3D 90mm 綠色重裝（GTXR90G）Ethicon Endo-Surgery, LLC

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