Cleared Traditional

ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS

K061156 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
Jul 2006
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K061156 is an FDA 510(k) clearance for the ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 3, 2006, 68 days after receiving the submission on April 26, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K061156 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2006
Decision Date July 03, 2006
Days to Decision 68 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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