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

    XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and

    K Number: K142646 · Decision Apr 30, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    2
    Review Days
    225

    Basic Information

    Device Name
    XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
    K Number
    K142646
    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
    Genadyne Biotechnologies, Inc
    Date Received
    September 17, 2014
    Decision Date
    April 30, 2015
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OMP), ordered by most recent decision date.

    Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Genadyne DUO NPWT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VERSA Negative Pressure Wound Therapy System (VCMPP-100)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Negative Pressure Wound Therapy Device (V-Move, V-Grand)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEXA™ NPWT System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Genadyne Biotechnologies, Inc

    K Number Device Name
    K221891 UNO Negative Pressure Wound Therapy System