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

    EXTRICARE

    K Number: K132225 · Decision May 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    10
    Review Days
    302

    Basic Information

    Device Name
    EXTRICARE
    K Number
    K132225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DEVON MEDICAL INC.
    Date Received
    July 17, 2013
    Decision Date
    May 15, 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 DEVON MEDICAL INC.

    K Number Device Name
    K131464 EXTRICARE NPWT FOOT DRESSING
    K131743 CIRONA DVT FOOT GARMENT
    K130571 DEVON CIRONA 6100 DVT
    K123959 CIRCUFLOW 5150
    K123647 CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
    K102582 ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
    K101523 CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE
    K100446 CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE
    K090664 DEVON ACCUBP CUFF