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

    SURGISURE TISSUE REMOVAL SYSTEM

    K Number: K103741 · Decision Mar 2, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    69

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    Basic Information

    Device Name
    SURGISURE TISSUE REMOVAL SYSTEM
    K Number
    K103741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interlace Medical, Inc.
    Date Received
    December 23, 2010
    Decision Date
    March 2, 2011
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Interlace Medical, Inc.

    K Number Device Name
    K102686 MYOSURE ROD LENS SCOPE SEALS
    K100559 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
    K091100 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
    K091465 MYOSURE ROD LENS HYSTEROSCOPE
    K081070 INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
    K073690 INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM