Cleared Traditional

K151156 - Fiagon Navigation System

K151156 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 336-day FDA review.

K151156 · Fiagon GmbH · Neurology device
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Apr 2016
Decision
336d
Days
Class 2
Risk

K151156 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 April 1, 2016 after a review of 336 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 - K151156

510(k) Number K151156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date April 01, 2016
Days to Decision 336 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
188d slower than avg
Panel avg: 148d · This submission: 336d
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 K151156.
Cranial Reducing Tubes
K162604 · Medtronic Navigation, Inc. · Dec 2016
CRW STEREOTACTIC SYSTEM
K160811 · Integra LifeSciences Corporation · Dec 2016
StealthStation System with Cranial Software
K153660 · Medtronic Navigation, Inc. · Sep 2016
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K152558 · Elekta Instrument AB · Mar 2016
Synergy Cranial
K150216 · Medtronic Navigation, Inc. · Jun 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · Medtronic Navigation, Inc. · Mar 2015