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

    “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set

    K Number: K252989 · Decision Feb 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    381
    Registration Numbers
    381
    Same Product Code
    430
    Applicant Total
    5
    Review Days
    155

    Basic Information

    Device Name
    “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set
    K Number
    K252989
    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
    September 18, 2025
    Decision Date
    February 20, 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

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    Other Clearances by Point Robotics MedTech, Inc.

    K Number Device Name
    K252755 POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
    K241130 “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
    K230087 “POINT” Kinguide Agile Hybrid Navigation System
    K220241 “POINT” Kinguide Robotic-Assisted Surgical System