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

    Intact Advance and Intact Excision XL, Intact BLES

    K Number: K142477 · Decision Dec 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    103

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    Basic Information

    Device Name
    Intact Advance and Intact Excision XL, Intact BLES
    K Number
    K142477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intact Medical Corporation
    Date Received
    September 3, 2014
    Decision Date
    December 15, 2014
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNW Instrument, Biopsy

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    Other Clearances by Intact Medical Corporation

    K Number Device Name
    K152596 Intact® Gen2 System
    K081057 INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
    K060413 INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE