Cleared Traditional

K163439 - NaviENT

K163439 is an FDA 510(k) clearance for NaviENT, manufactured by Claronav, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K163439 · Claronav, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
267d
Days
Class 2
Risk

K163439 is an FDA 510(k) clearance for the NaviENT. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Claronav, Inc. (Toronto, CA). The FDA issued a Cleared decision on September 1, 2017 after a review of 267 days - an extended review cycle.

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. Standard predicate reliance. 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 Claronav, Inc. devices

FDA 510(k) Submission Details - K163439

510(k) Number K163439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date September 01, 2017
Days to Decision 267 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
119d slower than avg
Panel avg: 148d · This submission: 267d
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 244
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K163439.
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