Cleared Special

K001339 - MRI FASTSYSTEM RETRACTOR SYSTEM

K001339 is an FDA 510(k) clearance for MRI FASTSYSTEM RETRACTOR SYSTEM, manufactured by Omni-Tract Surgical, Div. Minn. Scientific, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Special 510(k) pathway after a 20-day FDA review.

K001339 · Omni-Tract Surgical, Div. Minn. Scientific, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K001339

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

GAD Device Classification - Class 1, General Controls

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.

Regulatory Peers - GAD Retractor

All 99
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K001339.
DASH
K071775 · Ezsurgical · Aug 2007
APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR
K050256 · Apple Medical Corp. · Apr 2005
QUADRANT RETRACTOR SYSTEM
K043602 · Medtronic Sofamor Danek · Feb 2005
CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000
K980588 · Clarus Medical Systems, Inc. · Aug 1998
SCION SAPHENOUS VEIN HARVESTING SYSTEM
K963006 · Scion International, Inc. · Sep 1996
VILLALTA RETRACTOR
K943875 · Hct, Inc. · Nov 1994
K001339 · MRI FASTSYSTEM RETRACTOR SYSTEM
Download PDF FDA Summary Omni-Tract Surgical, …