Cleared Special

AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER

K061288 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery
Nov 2006
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K061288 is an FDA 510(k) clearance for the AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 2, 2006, 177 days after receiving the submission on May 9, 2006. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K061288 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2006
Decision Date November 02, 2006
Days to Decision 177 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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