BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COMPASS STEREOTACTIC POSITIONING SYSTEM

    K Number: K871046 · Decision May 8, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    5
    Review Days
    52

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COMPASS STEREOTACTIC POSITIONING SYSTEM
    K Number
    K871046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Stereotactic Medical Systems, Inc.
    Date Received
    March 17, 1987
    Decision Date
    May 8, 1987
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

    Similar 510(k) Clearances

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

    Zeta Navigation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Stealth AXiS Cranial clinical application

    FDA 510(k)
    FDA Class 2 ·Neurology

    NeuroAlign software

    FDA 510(k)
    FDA Class 2 ·Neurology

    SOLOPASS 2.0 System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Ball Joint Guide Array (66295)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EZ-FIDUCIALS

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

    Other Clearances by Stereotactic Medical Systems, Inc.

    K Number Device Name
    K896156 COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEM
    K884415 EP-100 (SERIES)
    K883653 EP-100 INFUSION PUMP
    K862220 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM