Cleared Traditional

K200420 - Echelon Contour Curved Cutter with blue...

K200420 is the FDA 510(k) clearance for Echelon Contour Curved Cutter with blue... 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 130-day FDA review.

K200420 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
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Jun 2020
Decision
130d
Days
Class 2
Risk

K200420 is an FDA 510(k) clearance for the Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter.... 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 June 29, 2020 after a review of 130 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 K200420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2020
Decision Date June 29, 2020
Days to Decision 130 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
15d slower than avg
Panel avg: 115d · This submission: 130d
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 Consultant

Ethicon Endo-Surgery, Inc.
Ruth James

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDW Staple, Implantable

All 135
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K200420.
AEON Endoscopic Stapler
K201882 · Lexington Medical, Inc. · Oct 2020
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K201280 · Ethicon Endo-Surgery, LLC · Jul 2020
Signia Stapler (with new software)
K201672 · Covidien · Jul 2020
GIA Stapler with Tri-Staple Technology
K192720 · Covidien · Mar 2020
EEA Circular Stapler with Tri-Staple Technology
K192330 · Covidien · Jan 2020
TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool
K190884 · Datascope Corp. · Dec 2019