BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

    K Number: K252755 · Decision Jan 23, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    5
    Review Days
    147

    Basic Information

    Device Name
    POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
    K Number
    K252755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Point Robotics MedTech, Inc.
    Date Received
    August 29, 2025
    Decision Date
    January 23, 2026
    Product Code
    OLO
    Advisory Committee
    Neurology
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLO Orthopedic Stereotaxic Instrument

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OLO), ordered by most recent decision date.

    Dynamis Robotic Surgical System

    FDA 510(k)
    FDA Class 2 ·Neurology

    CORUS™ Navigation System-GN

    FDA 510(k)
    FDA Class 2 ·Neurology

    SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    Navigated LLIF Impactable Tracker

    FDA 510(k)
    FDA Class 2 ·Neurology

    CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ion-C Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all

    Other Clearances by Point Robotics MedTech, Inc.

    K Number Device Name
    K252989 “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
    K241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
    K230087 “POINT” Kinguide Agile Hybrid Navigation System
    K220241 “POINT” Kinguide Robotic-Assisted Surgical System