K252739

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)

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 PR · US
Product code: GDW — Staple, Implantable
Decision date: 2025-12-17
Date received: 2025-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

510(k) Summary (official FDA PDF): K252739.pdf

Official FDA record: K252739

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.