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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K252739
Device Name 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)
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Heidi Calderon
Correspondent
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Correspondent Contact Heidi Calderon
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/28/2025
Decision Date 12/17/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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