Cleared Traditional

K163209 - Fiagon Navigation System

K163209 is an FDA 510(k) clearance for Fiagon Navigation System, manufactured by Fiagon GmbH. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K163209 · Fiagon GmbH · Neurology device
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Sep 2017
Decision
303d
Days
Class 2
Risk

K163209 is an FDA 510(k) clearance for the Fiagon Navigation System. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Fiagon GmbH (Hennigsdorf, DE). The FDA issued a Cleared decision on September 14, 2017 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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. Elevated predicate reliance profile. 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 Fiagon GmbH devices

FDA 510(k) Submission Details - K163209

510(k) Number K163209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2016
Decision Date September 14, 2017
Days to Decision 303 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 148d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 243
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K163209.
ROSA BRAIN (v3.0.0.5)
K172444 · Medtech S.A · Mar 2018
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
Leksell Vantage Stereotactic System
K171123 · Elekta Instrument AB · Sep 2017
StealthConnect Remote Viewing, Planning and Collaboration System
K162655 · Medtronic Navigation, Inc. · Apr 2017
StealthStation S8 System Platforms and StealthStation Cranial Software
K162309 · Medtronic Navigation, Inc. · Mar 2017
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
K162929 · Stryker Corporation · Feb 2017