BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ClearPoint Neuro Inc.

    Reg #: 3028006458 · FEI: 3028006458 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    17

    Registration Details

    Registration Name
    ClearPoint Neuro Inc.
    Registration Number
    3028006458
    FEI Number
    3028006458
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6349 Paseo Del Lago
    City
    Carlsbad
    State
    CA
    ZIP
    92011
    Country
    US

    Regulatory Submissions

    510(k) Number
    K132436

    Owner / Operator

    Firm Name
    ClearPoint Neuro, Inc.
    Operator Number
    9038590
    Address
    120 S Sierra Ave
    City
    Solana Beach
    State
    CA
    Postal Code
    92075
    Country
    US
    Correspondent
    Megan Faulkenberry

    Products

    Device Name Product Code
    Instrument, Manual, Surgical, General Use MDM
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Neurological Stereotaxic Instrument HAW
    Brain Intraparenchymal Infusion Cannula SDG
    Drape, Surgical, Antimicrobial KKX
    Shunt, Central Nervous System And Components JXG
    Device, Monitoring, Intracranial Pressure GWM
    Coil, Magnetic Resonance, Specialty MOS
    Holder, Head, Neurosurgical (Skull Clamp) HBL
    Automated Radiological Image Processing Software QIH
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Instrument, Surgical, Non-Powered HAO
    Drape, Surgical, Exempt PUI
    Screwdriver, Surgical LRZ
    Endoscope, Neurological GWG
    Cannula, Ventricular HCD

    Proprietary Names

    SmartFlow Loading Fixture VARIOGUIDE DRILL KIT Bone Screw Fiducials ClearPoint System (Software Version 3) SmartFlow Neuro Cannula MRI Neuro Drape ClearPoint System (Software Version 2) IRRAflow Long Extension IMRIS 1.5T Inflexion Head Frame SmartTwist MRI Hand Drill, SmartTip Drill Bit Kit Mobile Equipment Cart IRRAflow Active Fluid Exchange System (AFES) IRRAflow Bolt Bladed Lancet Cranial Access Kit Flexible Self Adhesive Equipment Cover SF M6 BOLT DRIVER MR Hex Key Bone Anchor Head Fixation Arc ClearPoint Array System (Version 1.2) ClearPoint Pursuit SmartFrame OR System ClearPointer Optical Navigation Wand SmartFlow Long Extension IMRIS 3T

    Establishment Types

    Manufacture Medical Device