Cleared Traditional

K011683 - NURVO 9000 ENDOCAVITARY COILS

K011683 is an FDA 510(k) clearance for NURVO 9000 ENDOCAVITARY COILS, manufactured by Usa Instruments, Inc.. The device is a Class 2 Radiology device width product code MOS cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K011683 · Usa Instruments, Inc. · Radiology device
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Dec 2001
Decision
194d
Days
Class 2
Risk

K011683 is an FDA 510(k) clearance for the NURVO 9000 ENDOCAVITARY COILS. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Usa Instruments, Inc. (Aurora, US). The FDA issued a Cleared decision on December 10, 2001 after a review of 194 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Usa Instruments, Inc. devices

Submission Details

510(k) Number K011683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date December 10, 2001
Days to Decision 194 days
Submission Type Traditional
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
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 311
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K011683.
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · Mri Devices Corp. · Jan 2002
SHOULDER COIL
K013541 · Usa Instruments, Inc. · Dec 2001
CRYSTAL 5000 PHASES ARRAY TMJ COIL
K013528 · Usa Instruments, Inc. · Dec 2001
CARDIOVASCULAR ARRAY
K013810 · W.L. Gore & Associates, Inc. · Nov 2001
HRH-127-ALLEGRA HEAD ARRAY COIL
K013508 · Mri Devices Corp. · Nov 2001
HNC-63-INT NEUROVASCULAR ARRAY COIL
K013602 · Mri Devices Corp. · Nov 2001