Cleared Traditional

NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION

K060967 · Stereotaxis, Inc. · Neurology

Oct 2006

Decision

195d

Days

Class 2

Risk

About This 510(k) Submission

K060967 is an FDA 510(k) clearance for the NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION, a System, Catheter Or Guidewire, Steerable (magnetic) (Class II — Special Controls, product code NDQ), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 19, 2006, 195 days after receiving the submission on April 7, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number	K060967 FDA.gov
FDA Decision	Cleared 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