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

    MINI LAP RETRACTORS

    K Number: K093449 · Decision Feb 12, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    99

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    Basic Information

    Device Name
    MINI LAP RETRACTORS
    K Number
    K093449
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mini Lap Technologies, Inc.
    Date Received
    November 5, 2009
    Decision Date
    February 12, 2010
    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 Mini Lap Technologies, Inc.

    K Number Device Name
    K101101 MINI-TONG
    K083754 MINI LAP ELECTROCAUTERY INSTRUMENTS
    K070686 MINI LAP INSTRUMENTS
    K070352 MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM