Cleared Special

K031089 - GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY

K031089 is the FDA 510(k) clearance for GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY by W.L. Gore & Associates, Inc.. It is a Class 2 Radiology device (product code MOS) cleared through the Special 510(k) pathway after a 31-day FDA review.

K031089 · W.L. Gore & Associates, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
31d
Days
Class 2
Risk

K031089 is an FDA 510(k) clearance for the GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Newark, US). The FDA issued a Cleared decision on May 8, 2003 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K031089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date May 08, 2003
Days to Decision 31 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 107d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 309
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K031089.
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K031056 · Usa Instruments, Inc. · May 2003
PRIMA III TOTALSENSE TORSO COIL
K030371 · Usa Instruments, Inc. · May 2003
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K030953 · Ge Medical Systems, Inc. · Apr 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · Ge Medical Systems, Inc. · Mar 2003