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

    MYOSURE ROD LENS SCOPE SEALS

    K Number: K102686 · Decision Oct 15, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    MYOSURE ROD LENS SCOPE SEALS
    K Number
    K102686
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interlace Medical, Inc.
    Date Received
    September 17, 2010
    Decision Date
    October 15, 2010
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Interlace Medical, Inc.

    K Number Device Name
    K103741 SURGISURE TISSUE REMOVAL SYSTEM
    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