Cleared Traditional

AUTO SUTURE MICRO SURGICLIP CLIP APPLIER

K001450 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery
Jul 2000
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K001450 is an FDA 510(k) clearance for the AUTO SUTURE MICRO SURGICLIP 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 July 18, 2000, 71 days after receiving the submission on May 8, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K001450 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2000
Decision Date July 18, 2000
Days to Decision 71 days
Submission Type Traditional
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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