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FDA 510(k)

ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)

K番号: K252739 · 2025-12-17

申請者Ethicon Endo-Surgery, LLC
決定日2025-12-17
製品コードGDW
諮問委員会SU
決定Substantially Equivalent

医療機器の概要

ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) 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 2025-12-17 under 510(k) number K252739. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)?

ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K252739.

When did ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) receive FDA 510(k) clearance?

ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252739.

Who is the listed applicant for ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)?

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

What is the FDA product code for ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)?

The FDA product code for ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) is GDW.

関連する臨床試験

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751膀胱癌を診断するための人工知能（AI）アシストドのUro-Camカテーテル評価システムNOT_YET_RECRUITING

申請者としてEthicon Endo-Surgery, LLCを記載するその他の記録

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)

すべての35件のデバイスを表示 →

関連機器（コード：GDW）

関連レコードは、名称、製品コード、その他のメタデータを使用して自動的にマッチングされます。マッチは検証された臨床的、科学的、企業的、または規制上の関係を確立するものではありません。リンクされた公式情報源をご確認ください。

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part of Medtronic)K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLCK243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)Ethicon Endo-Surgery, LLCK241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)Ethicon Endo-Surgery, LLC

公式ソース

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