Cleared Traditional

K241327 - Navient Image Guide Navigation System (...

K241327 is an FDA 510(k) clearance for Navient Image Guide Navigation System (..., manufactured by Claronav. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K241327 · Claronav · Neurology device
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Feb 2025
Decision
271d
Days
Class 2
Risk

K241327 is an FDA 510(k) clearance for the Navient Image Guide Navigation System (955-NC-NC), Cranial. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Claronav (Toronto, CA). The FDA issued a Cleared decision on February 5, 2025 after a review of 271 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 devices

FDA 510(k) Submission Details - K241327

510(k) Number K241327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date February 05, 2025
Days to Decision 271 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
123d slower than avg
Panel avg: 148d · This submission: 271d
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 242
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K241327.
Ball Joint Guide Array (66295)
K250893 · Bayer Medical Care, Inc. · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · Brain Navi Biotechnology Co., Ltd. · May 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
K243698 · Brainlab AG · Jan 2025
ClearPoint System (Software Version 3.0)
K243657 · ClearPoint Neuro, Inc. · Jan 2025
Geniant Cranial (Navigated Neurosurgical Positioning Robot)
K241333 · KOH YOUNG TECHNOLOGY, Inc. · Jan 2025