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FDA 510(k)

ECHELON 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)

K 號:K223760 · 2023-03-15

決定日期2023-03-15
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 LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) 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 2023-03-15 under 510(k) number K223760. 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 LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)?

ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Ethicon Endo-Surgery. The 510(k) number is K223760.

When did ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) receive FDA 510(k) clearance?

ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) received FDA 510(k) clearance on 2023-03-15, under 510(k) number K223760.

Who is the listed applicant for ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)?

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 ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)?

The FDA product code for ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) 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。

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。

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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