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

    XLR8 PLUS (XLR8+)

    K Number: K141437 · Decision Sep 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    10
    Review Days
    112

    Basic Information

    Device Name
    XLR8 PLUS (XLR8+)
    K Number
    K141437
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GENADYNE BIOTECHNOLOGIES, INC.
    Date Received
    May 30, 2014
    Decision Date
    September 19, 2014
    Product Code
    OMP
    Advisory Committee
    General, Plastic Surgery
    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
    OMP Negative Pressure Wound Therapy Powered Suction Pump

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    Other Clearances by GENADYNE BIOTECHNOLOGIES, INC.

    K Number Device Name
    K161599 UNO Negative Pressure Wound Therapy System
    K143726 XLR8 PLUS (XLR8+)
    K141961 GENADYNE SPIRO FOAM DRESSING KIT
    K112856 LUCINA-MELODI
    K102516 LUCINA MODEL MELODI
    K092992 A4-XLR8 FOAM DRESSING
    K090638 GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
    K082676 GENADYNE A4 WOUND VACUUM SYSTEM
    K080745 GENADYNE A4 POWERED SUCTION PUMP