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ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); — Ethicon Endo-Surgery, LLC (510(k) K25

ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); — Ethicon Endo-Surgery, LLC (510(k) K25 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S);; Applican

Device nameETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S);
ApplicantEthicon Endo-Surgery, LLC
Clearance track510(k)
Submission numberK250835
DecisionSubstantially Equivalent
Decision date2025-05-14
Date received2025-03-20
Product codeGDW
Device class2
Medical specialtyGeneral, Plastic Surgery
Applicant locationPR, US
SourceopenFDA device

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