Cleared Traditional

NaviNetics Reusable Stereotactic System (NN1000) (K231392) - FDA 510(k) Clearance

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

K231392 · Navinetics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
63d
Days
Class 2
Risk

K231392 is an FDA 510(k) clearance for the NaviNetics Reusable Stereotactic System (NN1000). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Navinetics, Inc. (Rochester, US). The FDA issued a Cleared decision on July 14, 2023 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Navinetics, Inc. devices

Submission Details

510(k) Number K231392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2023
Decision Date July 14, 2023
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
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 159
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K231392.
Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
K223288 · Brainlab AG · Jul 2023
ROSA ONE Brain Application
K231103 · Medtech S.A.S · Jul 2023
Sinobot X1
K220072 · Sinovation (Beijing) Medical Technology Co., Ltd. · Jun 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
K223552 · Brainlab AG · Apr 2023
Localite TMS Navigator TS
K223577 · Localite GmbH · Apr 2023