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

    MINI LAP INSTRUMENTS

    K Number: K070686 · Decision Apr 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    69
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    MINI LAP INSTRUMENTS
    K Number
    K070686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mini Lap Technologies, Inc.
    Date Received
    March 12, 2007
    Decision Date
    April 5, 2007
    Product Code
    OCW
    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
    OCW Endoscopic Tissue Approximation Device

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    Other Clearances by Mini Lap Technologies, Inc.

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    K101101 MINI-TONG
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    K083754 MINI LAP ELECTROCAUTERY INSTRUMENTS
    K070352 MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM