Cleared Special

MRI FASTSYSTEM RETRACTOR SYSTEM

K001339 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · General & Plastic Surgery
May 2000
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K001339 is an FDA 510(k) clearance for the MRI FASTSYSTEM RETRACTOR SYSTEM, a Retractor (Class I — General Controls, product code GAD), submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 17, 2000, 20 days after receiving the submission on April 27, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K001339 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2000
Decision Date May 17, 2000
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GAD — Retractor
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800