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

    UNO Negative Pressure Wound Therapy System

    K Number: K180840 · Decision Nov 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    6
    Review Days
    245

    Basic Information

    Device Name
    UNO Negative Pressure Wound Therapy System
    K Number
    K180840
    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
    March 30, 2018
    Decision Date
    November 30, 2018
    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
    K243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
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    K221888 Genadyne Hybrid Foam Dressings
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    K143574 Melodi Prime Breast Pump