Cleared Traditional

Fiagon Navigation System (K163209) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163209 · Fiagon GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 160
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K163209.
neuromate Gen III
K180206 · Renishaw Mayfield Sarl · Apr 2018
ROSA BRAIN (v3.0.0.5)
K172444 · Medtech S.A · Mar 2018
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
K162929 · Stryker Corporation · Feb 2017
KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM
K122096 · KARL STORZ Endoscopy-America, Inc. · Sep 2012
IPLAN
K101627 · Brainlab AG · Jun 2011