Cleared Traditional

K060967 - NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

K060967 is an FDA 510(k) clearance for NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVI..., manufactured by Stereotaxis, Inc.. The device is a Class 2 Neurology device with product code NDQ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K060967 · Stereotaxis, Inc. · Neurology device
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Oct 2006
Decision
195d
Days
Class 2
Risk

K060967 is an FDA 510(k) clearance for the NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION. Classified as System, Catheter Or Guidewire, Steerable (magnetic) (product code NDQ), Class II - Special Controls.

Submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 19, 2006 after a review of 195 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1290 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stereotaxis, Inc. devices

FDA 510(k) Submission Details - K060967

510(k) Number K060967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2006
Decision Date October 19, 2006
Days to Decision 195 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 148d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDQ Device Classification - Class 2, Special Controls

Product Code NDQ System, Catheter Or Guidewire, Steerable (magnetic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 Neurology devices follow this clearance model.