Cleared Traditional

ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED

K141952 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
Nov 2014
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K141952 is an FDA 510(k) clearance for the ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, Inc. (Blue Ash, US). The FDA issued a Cleared decision on November 24, 2014, 129 days after receiving the submission on July 18, 2014. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K141952 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2014
Decision Date November 24, 2014
Days to Decision 129 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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