Cleared Traditional

Fusion Compact Navigation System

K153247 · Medtronic Navigation, Inc. · Ear, Nose, Throat

Feb 2016

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K153247 is an FDA 510(k) clearance for the Fusion Compact Navigation System, a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on February 18, 2016, 101 days after receiving the submission on November 9, 2015. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K153247 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 09, 2015
Decision Date	February 18, 2016
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.