Cleared Traditional

AUTO SUTUR ENDO GIA STAPLERS

K061095 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery
May 2006
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K061095 is an FDA 510(k) clearance for the AUTO SUTUR ENDO GIA STAPLERS, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 31, 2006, 42 days after receiving the submission on April 19, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K061095 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2006
Decision Date May 31, 2006
Days to Decision 42 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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