Cleared Traditional

K252739 - ETHICON™ 4000 45mm Compact Stapler (EC3DT45C) (FDA 510(k) Clearance)

Also includes:
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)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252739 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
111d
Days
Class 2
Risk

K252739 is an FDA 510(k) clearance for the ETHICON™ 4000 45mm Compact Stapler (EC3DT45C). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on December 17, 2025 after a review of 111 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K252739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 114d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GDW Staple, Implantable

All 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K252739.
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K241630 · Ethicon Endo-Surgery, LLC · Oct 2024
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