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

    SURGIVISION INC. CLEARPOINT SYSTEM

    K Number: K111073 · Decision Jun 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    9
    Review Days
    65

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    Basic Information

    Device Name
    SURGIVISION INC. CLEARPOINT SYSTEM
    K Number
    K111073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgi-Vision, Inc.
    Date Received
    April 18, 2011
    Decision Date
    June 22, 2011
    Product Code
    ORR
    Advisory Committee
    Neurology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

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    Other Clearances by Surgi-Vision, Inc.

    K Number Device Name
    K020790 INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
    K020495 INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
    K011781 INTERCEPT-URETHRAL MICROCOIL
    K003436 SURGI-VISION GUIDEWIRE COIL
    K002916 SURGI-VISION PROSTATE COIL
    K002345 SURGI-VISION URETHRAL COIL
    K994436 SURGI-VISION ESOPHAGEAL STYLET COIL
    K992193 ENDO-ESOPHAGEAL MR COIL