Cleared Traditional

K163523 - ECHELON CIRCULAR Powered Stapler

K163523 is the FDA 510(k) clearance for ECHELON CIRCULAR Powered Stapler by Ethicon Endo-Surgery, LLC. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K163523 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2017
Decision
124d
Days
Class 2
Risk

K163523 is an FDA 510(k) clearance for the ECHELON CIRCULAR Powered Stapler. 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 April 18, 2017 after a review of 124 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 K163523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2016
Decision Date April 18, 2017
Days to Decision 124 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
9d slower than avg
Panel avg: 115d · This submission: 124d
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 152
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K163523.
EEA Circular Stapler with Tri-Staple Technology
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AEON Endoscopic Stapler
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OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
K170278 · C.R. Bard, Inc. · May 2017
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
K163698 · C.R. Bard, Inc. · Apr 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien · Mar 2017
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
K163454 · Ethicon Endo-Surgery, LLC · Jan 2017