Cleared Traditional

K153247 - Fusion Compact Navigation System

K153247 is an FDA 510(k) clearance for Fusion Compact Navigation System, manufactured by Medtronic Navigation, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code PGW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K153247 · Medtronic Navigation, Inc. · Ear, Nose, Throat device
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Feb 2016
Decision
101d
Days
Class 2
Risk

K153247 is an FDA 510(k) clearance for the Fusion Compact Navigation System. Classified as Ear, Nose, And Throat Stereotaxic Instrument (product code PGW), Class II - Special Controls.

Submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on February 18, 2016 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 882.4560 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Navigation, Inc. devices

FDA 510(k) Submission Details - K153247

510(k) Number K153247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 90d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGW Device Classification - Class 2, Special Controls

Product Code PGW Ear, Nose, And Throat Stereotaxic Instrument
Device Class Class 2 - 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.
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - PGW Ear, Nose, And Throat Stereotaxic Instrument

All 36
Devices cleared under the same product code (PGW) and FDA review panel - the closest regulatory comparables to K153247.
EM ENT Navigated Suctions
K153555 · Medtronic Navigation, Inc. · Apr 2016
PointerShell Universal, PointerShell LS
K160479 · Fiagon GmbH · Mar 2016
GuideWire
K160369 · Fiagon GmbH · Mar 2016
FlexPointer 1.5 mm
K150473 · Fiagon GmbH · Apr 2015
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
K141456 · Fiagon GmbH · Oct 2014
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
K141551 · Stryker Corporate · Sep 2014