Cleared Traditional

AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT

K032696 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery
Dec 2003
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K032696 is an FDA 510(k) clearance for the AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT, 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 December 1, 2003, 90 days after receiving the submission on September 2, 2003. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K032696 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2003
Decision Date December 01, 2003
Days to Decision 90 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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