Cleared Special

K001339 - MRI FASTSYSTEM RETRACTOR SYSTEM (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K001339 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
20d
Days
Class 1
Risk

K001339 is an FDA 510(k) clearance for the MRI FASTSYSTEM RETRACTOR SYSTEM. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Omni-Tract Surgical, Div. Minn. Scientific, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 17, 2000 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omni-Tract Surgical, Div. Minn. Scientific, Inc. devices

Submission Details

510(k) Number K001339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 114d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.