Cleared Traditional

K223760 - ECHELON LINEAR™ 60 mm Cutter (GLC60) (FDA 510(k) Clearance)

Also includes:
ECHELON LINEAR™ 80mm Cutter (GLC80) ECHELON LINEAR™ 100 mm Cutter (GLC100) ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B) ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G) ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B) ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G) ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B) ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G)

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

K223760 · Ethicon Endo-Surgery · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
90d
Days
Class 2
Risk

K223760 is an FDA 510(k) clearance for the ECHELON LINEAR™ 60 mm Cutter (GLC60). Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery (Guaynabo, US). The FDA issued a Cleared decision on March 15, 2023 after a review of 90 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 devices

Submission Details

510(k) Number K223760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2022
Decision Date March 15, 2023
Days to Decision 90 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
24d faster than avg
Panel avg: 114d · This submission: 90d
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 K223760.
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