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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: HAW FDA class 2

    Neurological Stereotaxic Instrument

    Neurology

    View full classification →

    The Neurological Stereotaxic Instrument is a frame-based or frameless guidance device used in neurosurgery to precisely target specific intracranial coordinates for biopsy, electrode placement, ablation, or other procedures using a three-dimensional coordinate system referenced to external landmarks. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HAW under regulation 21 CFR 882.4560 in the Neurology specialty. No third-party review flag applies.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EZ-FIDUCIALS
    Stereotaxic Guiding Surgical Devices, NaoTrac S
    Navient Image Guide Navigation System (955-NC-NC), Cranial
    Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
    ClearPoint System (Software Version 3.0)
    Geniant Cranial (Navigated Neurosurgical Positioning Robot)
    FLASH EVD System (10-0002)
    Zeta Cranial Navigation System (ZNS131-US)
    Bone Anchor (NGS-BA-01)
    SmartFrame OR
    ClearPoint Bone Screw Fiducials
    ClearPointer Optical Navigation Wand
    Zeta Cranial Navigation System (ZNS131-US)
    ClearPoint System (Software Version 2.2)
    StealthStation Cranial Software, v3.1.5 (9735585)
    ClearPoint Array System (Version 1.2)
    Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
    Zeta Cranial Navigation System
    Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
    ROSA ONE Brain Application
    NaviNetics Reusable Stereotactic System (NN1000)
    Sinobot X1
    Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
    Localite TMS Navigator TS
    MagVenture TMS Atlas Neuro Navigation System
    Disposable Pre-calibrated Brain Biopsy Needle 2.0
    Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
    ClearPoint System
    Cranial EM System
    Disposable Brain Biopsy Needle 2.0
    Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
    ROSA ONE Brain application
    ClearPoint Array System (version 1.1)
    visor2 system
    StealthStation S8 Cranial v2.0
    Molecular Flow Simulations
    Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
    Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
    SOLOPASS System
    NaviNetics D1 Stereotactic System
    Disposable Pre-calibrated Suction
    ClearPoint Array System
    StealthStation Cranial Software v1.3.2
    Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
    StealthStation Cranial Software v1.3.0
    ROSA ONE Brain application
    Neural Navigator
    ClearPoint System and Accessories
    7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
    Stealth Autoguide System, Midas Rex Legend Depth Stop System

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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