Cleared Traditional

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)

K252739 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery
Dec 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K252739 is an FDA 510(k) clearance for 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), a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on December 17, 2025, 111 days after receiving the submission on August 28, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K252739 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2025
Decision Date December 17, 2025
Days to Decision 111 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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