Cleared Traditional

ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER

K051002 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery
May 2005
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K051002 is an FDA 510(k) clearance for the ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, 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 May 17, 2005, 27 days after receiving the submission on April 20, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K051002 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2005
Decision Date May 17, 2005
Days to Decision 27 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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