BEUDAMED
    Product Code: PDQ FDA class 2 21 CFR 874.1820

    Neurosurgical Nerve Locator

    Ear, Nose, Throat

    The Neurosurgical Nerve Locator is an ear, nose, and throat specialty device used to locate or monitor the function of spinal nerve roots or peripheral nerves during neurosurgery, helping surgeons identify and preserve neural structures. It falls under the Ear, Nose, Throat medical specialty and is classified as a Class 2 device under regulation 874.1820, requiring 510(k) premarket notification. These devices use electrical stimulation to elicit nerve responses and are essential tools in spine and cranial nerve surgery. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    35
    FEI Numbers
    58
    Registration Numbers
    58
    Unique Applicants
    20
    Years Active
    13

    Research product code PDQ in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PDQ
    Device Class
    FDA class 2
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 35 510(k) clearances via K numbers.

    K Number Device Name
    K253580 Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
    K243636 Neuralytix iD3 System (NTX-9001)
    K223438 TELIGEN System Peripheral Motor Nerve Stimulation Indications
    K221821 ATEC IOM Accessory Instruments
    K220160 PediGuard Threaded
    K203684 Neurosign V4 Intraoperative Nerve Monitor
    K201454 DSG Connect Technology
    K191723 ATEC IOM Accessory Instruments
    K190163 ALARA Neuro Access Kit
    K182617 ATEC IOM Accessory Instruments
    K182662 NAV PAK Needle, NIM NAV PAK Needle
    K181559 Neurosign V4 Intraoperative Nerve Monitor
    K180542 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe
    K173526 SENTIO MMG Gen 2
    K173134 SENTIO MMG Pedicle Access Needles
    K171807 ES2 Neuromonitoring Accessory Instruments
    K162313 NuVasive Next Generation NVM5 System
    K161893 Neuromonitoring Kit
    K152747 DSG Threaded Drill System
    K152942 NuVasiveNVM5 System
    K143641 NuVasive NVM5 System
    K142438 Nerve Monitoring Cable System
    K143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
    K141968 NUVASIVE NVM5 SYSTEM
    K140088 PHANTOM XL INSULATED DILATORS
    K131304 SENTIO MMG
    K132694 NUVASIVE NVM5 SYSTEM
    K133530 NUVASIVE EMG ENDOTRACHEAL TUBE
    K132138 RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE
    K132373 BIOMET ACCESS SYSTEM
    K123390 PEDIGUARD NERVE DETECTOR SYSTEM
    K130806 NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
    K120590 DILATOR TUBE SET
    K123307 NUVASIVE NVM5 SYSTEM
    K123589 CADWELL DISPOSABLE PROBE HANDLE

    FEI Numbers

    This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.