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FDA 510(k)

ECHELON 3000 45mm 縮版釘書機 (ECH45C);Echelon 3000 45mm 标準釘書機 (ECH45S);Echelon 3000 45mm 長釘書機 (ECH45L);Echelon 3000 60mm 縮版釘書機 (ECH60C);Echelon 3000 60mm 标準釘書機 (ECH60S);Echelon 3000 60mm 長釘書機 (ECH60L)

K 號:K241629 · 2024-07-03

決定日期2024-07-03
產品代碼GAG
諮詢委員會醫療設備規範文本翻譯如下: HO 注意:原文中未提供具體的醫療設備規範文本,因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於

器材摘要

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) 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 2024-07-03 under 510(k) number K241629. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) is a medical device that received FDA 510(k) clearance on 2024-07-03. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K241629.

When did ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) receive FDA 510(k) clearance?

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) received FDA 510(k) clearance on 2024-07-03, under 510(k) number K241629.

Who is the listed applicant for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

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 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)?

The FDA product code for ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) is GAG.

相關臨床試驗

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其他以 Ethicon Endo-Surgery, LLC 為申請人之記錄

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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:GAG)

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。

官方來源

在 FDA 資料庫中查看 →

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