Cleared Traditional

K243276 - ECHELON LINEAR™ Stapler 30mm Stapler (GTX30) (FDA 510(k) Clearance)

Also includes:
ECHELON LINEAR™ Stapler 60mm Stapler (GTX60) ECHELON LINEAR™ Stapler 90mm Stapler (GTX90) ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B) ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G) ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B) ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G) ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B) ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)

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

K243276 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
132d
Days
Class 2
Risk

K243276 is an FDA 510(k) clearance for the ECHELON LINEAR™ Stapler 30mm Stapler (GTX30). 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 February 25, 2025 after a review of 132 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 K243276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2024
Decision Date February 25, 2025
Days to Decision 132 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
18d slower than avg
Panel avg: 114d · This submission: 132d
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
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