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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 149d · 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 Consultant

Hogan Lovells US LLP
Yarmela Pavlovic

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 387
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K163209.
Microscope Navigation Software
K172820 · Brainlab AG · Mar 2018
neuro inspire
K163666 · Rensihaw Plc · Sep 2017
Leksell Vantage Stereotactic System
K171123 · Elekta Instrument AB · Sep 2017
NaviENT
K163439 · Claronav, Inc. · 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