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

    INSULSCAN INSULATION TESTING SYSTEM

    K Number: K991424 · Decision Jul 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    90

    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
    INSULSCAN INSULATION TESTING SYSTEM
    K Number
    K991424
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicor Corp.
    Date Received
    April 23, 1999
    Decision Date
    July 22, 1999
    Product Code
    HFG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

    Similar 510(k) Clearances

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

    Acessa ProVu System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACESSA GUIDANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ACESSA GUIDANCE HANDPIECE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    THE ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MICROMED PD-8K INSULATION DEFECT DETECTOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ENDO-TECH LTD., TIPS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all