Cleared Traditional

K233155 - ClearPointer Optical Navigation Wand

K233155 is an FDA 510(k) clearance for ClearPointer Optical Navigation Wand, manufactured by ClearPoint Neuro, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K233155 · ClearPoint Neuro, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
107d
Days
Class 2
Risk

K233155 is an FDA 510(k) clearance for the ClearPointer Optical Navigation Wand. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by ClearPoint Neuro, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 12, 2024 after a review of 107 days - within the typical 510(k) review window.

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 ClearPoint Neuro, Inc. devices

FDA 510(k) Submission Details - K233155

510(k) Number K233155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date January 12, 2024
Days to Decision 107 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
41d faster than avg
Panel avg: 148d · This submission: 107d
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 K233155.
Bone Anchor (NGS-BA-01)
K233703 · ClearPoint Neuro, Inc. · Apr 2024
SmartFrame OR
K233141 · ClearPoint Neuro, Inc. · Jan 2024
ClearPoint Bone Screw Fiducials
K233144 · ClearPoint Neuro, Inc. · Jan 2024
Zeta Cranial Navigation System (ZNS131-US)
K233903 · Zeta Surgical, Inc. · Jan 2024
ClearPoint System (Software Version 2.2)
K233243 · ClearPoint Neuro, Inc. · Nov 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · Medtronic Navigation, Inc. · Oct 2023