Cleared Special

Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm

K202665 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery
Oct 2020
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K202665 is an FDA 510(k) clearance for the Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm, 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 October 15, 2020, 31 days after receiving the submission on September 14, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K202665 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2020
Decision Date October 15, 2020
Days to Decision 31 days
Submission Type Special
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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