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

    SURGI-VISION ESOPHAGEAL STYLET COIL

    K Number: K994436 · Decision Mar 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    9
    Review Days
    75

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    Basic Information

    Device Name
    SURGI-VISION ESOPHAGEAL STYLET COIL
    K Number
    K994436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgi-Vision, Inc.
    Date Received
    December 30, 1999
    Decision Date
    March 14, 2000
    Product Code
    MOS
    Advisory Committee
    Radiology
    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
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Surgi-Vision, Inc.

    K Number Device Name
    K111073 SURGIVISION INC. CLEARPOINT SYSTEM
    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
    K992193 ENDO-ESOPHAGEAL MR COIL