Cleared Traditional

Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green

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

About This 510(k) Submission

K200420 is an FDA 510(k) clearance for the Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on June 29, 2020, 130 days after receiving the submission on February 20, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K200420 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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