Cleared Traditional

K250835 - ETHICON 4000 60mm Compact Stapler (EC3D60C) (FDA 510(k) Clearance)

Also includes:
ETHICON 4000 60mm Standard Stapler (EC3D60S) ETHICON 4000 60mm Long Stapler (EC3D60L) ETHICON 3D 60mm White Reload (ER60W) ETHICON 3D 60mm Blue Reload (ER60B) ETHICON 3D 60mm Green Reload (ER60G) ETHICON 3D 60mm Black Reload (ER60T)

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

K250835 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
55d
Days
Class 2
Risk

K250835 is an FDA 510(k) clearance for the ETHICON 4000 60mm Compact Stapler (EC3D60C). 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 May 14, 2025 after a review of 55 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K250835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2025
Decision Date May 14, 2025
Days to Decision 55 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
59d faster than avg
Panel avg: 114d · This submission: 55d
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 K250835.
Tri-staple 2.0™ Reloads
K253657 · Covidien (Part of Medtronic) · Apr 2026
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · Ethicon Endo-Surgery, LLC · Dec 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · Ethicon Endo-Surgery, LLC · Feb 2025
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · Ethicon Endo-Surgery, LLC · Oct 2024
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series)
K242679 · Fengh Medical Co., Ltd. · Oct 2024
EEA Circular Stapler with Tri-Staple Technology
K221771 · Covidien · Nov 2022